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Thera-band Resisted Treadmill Training for Chronic Stroke Patients

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Treadmill training combined with/ without thera-band
Sponsored by
Sang-I Lin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. the diagnosis of first time unilateral stroke more than 6 months before
  2. the ability to walk for at least 15 m without person assistance
  3. apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s
  4. resting blood pressure lower than 150/90 mmHg.

Exclusion Criteria:

  1. older than 75 years
  2. inability to follow the experimental instructions or procedures
  3. any pain, inflammation, or other conditions that could affect walking
  4. medically unstable.

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treadmill training combined with thera-band

Treadmill training alone

Arm Description

Participants will receive walking training on treadmill with thera-band at the waist. The direction of the thera-band resistance will be straight backward, backward-toward-right, and backward-toward-left. For each direction, the level of resistance and treadmill speed will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'.

Participants will receive treadmill walking training at a speed that will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. For each session, there will be three 10-min treadmill walking bouts.

Outcomes

Primary Outcome Measures

stride characteristics
Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle. Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure.
Walking oxygen uptake
A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.
Balance
Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2021
Last Updated
April 14, 2022
Sponsor
Sang-I Lin
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1. Study Identification

Unique Protocol Identification Number
NCT04974840
Brief Title
Thera-band Resisted Treadmill Training for Chronic Stroke Patients
Official Title
Effects of Thera-band Resisted Treadmill Training on Walking Ability in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sang-I Lin

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.
Detailed Description
This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treadmill training combined with thera-band
Arm Type
Experimental
Arm Description
Participants will receive walking training on treadmill with thera-band at the waist. The direction of the thera-band resistance will be straight backward, backward-toward-right, and backward-toward-left. For each direction, the level of resistance and treadmill speed will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'.
Arm Title
Treadmill training alone
Arm Type
Active Comparator
Arm Description
Participants will receive treadmill walking training at a speed that will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. For each session, there will be three 10-min treadmill walking bouts.
Intervention Type
Behavioral
Intervention Name(s)
Treadmill training combined with/ without thera-band
Intervention Description
Treadmill walking training with thera-band Treadmill walking training without thera-band
Primary Outcome Measure Information:
Title
stride characteristics
Description
Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle. Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure.
Time Frame
8 weeks
Title
Walking oxygen uptake
Description
A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.
Time Frame
8 weeks
Title
Balance
Description
Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: the diagnosis of first time unilateral stroke more than 6 months before the ability to walk for at least 15 m without person assistance apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s resting blood pressure lower than 150/90 mmHg. Exclusion Criteria: older than 75 years inability to follow the experimental instructions or procedures any pain, inflammation, or other conditions that could affect walking medically unstable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang-I Lin
Phone
886-6-2757575
Ext
5020
Email
lin31@mail.ncku.edu.tw
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-I Lin, PhD
Phone
+886-6-235-3535
Ext
5020
Email
lin31@mail.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thera-band Resisted Treadmill Training for Chronic Stroke Patients

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