search
Back to results

The Effects of Plantar Flexion Training in People With Chronic Stroke

Primary Purpose

Stroke, Hemiplegic Gait

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skateboard exercise at an incline angle of 0 degrees and 50% body weight
Skateboard exercise at an incline angle of 5 degrees and 50% body weight
Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight
Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight
Control 4-week exercise intervention
Experimental 4-week exercise intervention
Over-ground multi-directional gait training
Home exercise
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation, walking limitations, gait rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be able to perform five times sit to stand test without the use of upper extremities
  • Must have 10 degrees of passive ankle dorsiflexion measured in standing
  • Must be able to walk with supervision level assistance with no assistive device

Exclusion criteria:

  • Currently receiving physical therapy
  • History of orthopedic ankle instability
  • Lacking knee extension to neutral
  • Unable to understand English
  • Unable to follow multi-step commands
  • History of orthopedic pathology that prevents completion of experimental condition
  • Pain with weight bearing on paretic LE
  • Received Botox to the plantar flexors within the last three months or phenol injections within the last six months
  • Walk with a longer nonparetic step length than paretic step length

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

Arm Description

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Outcomes

Primary Outcome Measures

Step length asymmetry ratio as assessed by the GAITRite®
The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Muscle activity of the soleus as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Plantar flexion torque as assessed by isokinetic dynamometry
Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Muscle activity of the soleus as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

Secondary Outcome Measures

Gait speed as assessed by the GAITRite®
Self-selected gait speed will be acquired using the GAITRite®.
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Muscle activity of the soleus as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Quality of life as assessed by the Stroke Impact Scale
The physical domain of the Stroke Impact Scale will used to determine quality of life. The Stroke Impact Scale is a self-report measure designed to capture eight domains of health status. The physical domain has nine items that are rated using a 5 point Likert scale in terms of how difficult certain physical tasks are. The domains are scored separately using a transformed scale formula: [(raw score - lowest possible raw score) / highest possible raw score] x 100. A composite score will be assessed.

Full Information

First Posted
May 24, 2018
Last Updated
September 29, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University
search

1. Study Identification

Unique Protocol Identification Number
NCT03548090
Brief Title
The Effects of Plantar Flexion Training in People With Chronic Stroke
Official Title
The Effects of Plantar Flexion Training on Plantar Flexion Activation, Torque, and Step Length Asymmetry in People With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors. The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke. The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke. The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.
Detailed Description
Description of Arms: This study has three phases. The first phase is performed in a cross-over fashion. Participants will stand on two different incline angles on the paretic LE and simultaneously move a small skateboard forward with the non-paretic LE. The testing order for the two different incline angles will be randomized, and all participants will be required to complete both incline angle conditions within a single test session. The second phase will also be performed in a cross-over fashion. Participants will stand with three different percentages of body weight on their paretic LE while moving the skateboard forward with the non-paretic LE. The testing order for the three body weight percentages will be randomized. All participants will be required to complete all three body weight conditions within a single test session. In the third phase, participants will be randomized to either a control 4-week exercise intervention (conventional physical therapy) or a 4-week experimental exercise intervention (plantar flexion training). Both the control and exerimental arms will complete over-ground multi-directional gait training and home exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegic Gait
Keywords
stroke rehabilitation, walking limitations, gait rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)
Arm Title
2
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)
Arm Title
3
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)
Arm Title
4
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)
Arm Title
5
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)
Arm Title
6
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)
Arm Title
7
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)
Arm Title
8
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)
Arm Title
9
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)
Arm Title
10
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)
Arm Title
11
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)
Arm Title
12
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)
Arm Title
13
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
14
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
15
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
16
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
17
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
18
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
19
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
20
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
21
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
22
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
23
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)
Arm Title
24
Arm Type
Experimental
Arm Description
Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)
Intervention Type
Other
Intervention Name(s)
Skateboard exercise at an incline angle of 0 degrees and 50% body weight
Intervention Description
Participants will stand on a specified incline angle (0 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Intervention Type
Other
Intervention Name(s)
Skateboard exercise at an incline angle of 5 degrees and 50% body weight
Intervention Description
Participants will stand on a specified incline angle (5 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Intervention Type
Other
Intervention Name(s)
Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight
Intervention Description
Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (75%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Intervention Type
Other
Intervention Name(s)
Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight
Intervention Description
Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (90%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Intervention Type
Other
Intervention Name(s)
Control 4-week exercise intervention
Other Intervention Name(s)
conventional physical therapy
Intervention Description
This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The control group will perform three sets of ten repetitions of the following 4 exercises, for a total of 120 repetitions: 1) standing hip abduction against green theraband resistance with upper extremity support, 2) sit to stands from chair with no upper extremity support, 3) bilateral calf raises with upper extremity support, and 4) right and left weight shifting exercises using a wobble board with upper extremity support available if needed.
Intervention Type
Other
Intervention Name(s)
Experimental 4-week exercise intervention
Other Intervention Name(s)
Plantar flexion training
Intervention Description
This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The experimental group will perform the skateboard exercise with the optimal parameters established during studies 1 and 2 (that is, an incline angle of either 0 or 5 degrees and a body weight percentage of 50%, 75%, or 90%)--the forward and backward speed of the skateboard will be cued with a metronome that will set at a beats per minute that matches the foot strike cadence of someone walking at 0.7 m/s, and the magnitude of forward excursion of the skateboard will be individualized to the participant based on GAITRite® data (that is, step length of the non-paretic LE).
Intervention Type
Other
Intervention Name(s)
Over-ground multi-directional gait training
Intervention Description
In the over-ground multi-directional gait protocol, the participant will walk 750 steps forward, 50 steps backward, and 200 side steps over level surfaces. The over ground gait training will focus on equalizing step length while performing multi-directional gait training.
Intervention Type
Other
Intervention Name(s)
Home exercise
Intervention Description
Home exercise consists of three sets of ten repetitions of the following three exercises to be performed on non-therapy days over the four weeks of phase 3: 1) sit to stands from chair with no upper extremity support, 2) bilateral calf raises with hand support, and 3) resisted side stepping to the non-paretic side using a green theraband with upper extremity support.
Primary Outcome Measure Information:
Title
Step length asymmetry ratio as assessed by the GAITRite®
Description
The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.
Time Frame
baseline, 6 weeks (relative to the phase 3 intervention)
Title
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Description
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Time Frame
on the 1 day of the phase 1 intervention
Title
Muscle activity of the soleus as assessed by surface EMG
Description
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Time Frame
on the 1 day of the phase 1 intervention
Title
Plantar flexion torque as assessed by isokinetic dynamometry
Description
Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.
Time Frame
baseline, 6 weeks (relative to the phase 3 intervention)
Title
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Description
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Time Frame
on the 1 day of the phase 2 intervention
Title
Muscle activity of the soleus as assessed by surface EMG
Description
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Time Frame
on the 1 day of the phase 2 intervention
Secondary Outcome Measure Information:
Title
Gait speed as assessed by the GAITRite®
Description
Self-selected gait speed will be acquired using the GAITRite®.
Time Frame
baseline, 6 weeks (relative to the phase 3 intervention)
Title
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Description
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Time Frame
baseline, 6 weeks (relative to the phase 3 intervention)
Title
Muscle activity of the soleus as assessed by surface EMG
Description
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Time Frame
baseline, 6 weeks (relative to the phase 3 intervention)
Title
Quality of life as assessed by the Stroke Impact Scale
Description
The physical domain of the Stroke Impact Scale will used to determine quality of life. The Stroke Impact Scale is a self-report measure designed to capture eight domains of health status. The physical domain has nine items that are rated using a 5 point Likert scale in terms of how difficult certain physical tasks are. The domains are scored separately using a transformed scale formula: [(raw score - lowest possible raw score) / highest possible raw score] x 100. A composite score will be assessed.
Time Frame
baseline, 6 weeks (relative to the phase 3 intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be able to perform five times sit to stand test without the use of upper extremities Must have 10 degrees of passive ankle dorsiflexion measured in standing Must be able to walk with supervision level assistance with no assistive device Exclusion criteria: Currently receiving physical therapy History of orthopedic ankle instability Lacking knee extension to neutral Unable to understand English Unable to follow multi-step commands History of orthopedic pathology that prevents completion of experimental condition Pain with weight bearing on paretic LE Received Botox to the plantar flexors within the last three months or phenol injections within the last six months Walk with a longer nonparetic step length than paretic step length
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Wingard, DPT
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Plantar Flexion Training in People With Chronic Stroke

We'll reach out to this number within 24 hrs