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Weight-bearing Training in Stroke Patients.

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
WB Training with external feedback
WB Training without external feedback
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cerebrovascular disease, rehabilitation, walking, balance, mobility

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months)
  • Age at least 40 years to 74 years
  • Body mass index (BMI) between 18.5- 29.9 kg/m^2
  • Ability of independent walking over at least 10 meters with or without a walking device
  • Ability to rise from a chair with or without using their arms
  • Ability to follow a command used in the study

Exclusion Criteria:

any conditions that may affect ambulatory ability or ability to participate in the study, such as

  • Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens
  • Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS)
  • Deformity in the limbs or spine that affect ambulatory ability
  • Modified Ashworth Scale (MAS) more 2 score
  • Unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.

Sites / Locations

  • Faculty of Associated Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WB Training with external feedback

WB Training without external feedback

Arm Description

WB during sit-to-stand with external feedback for 10 minute and then, WB during stepping training with external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes.

WB during sit-to-stand without external feedback for 10 minute and then, WB during stepping training without external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes.

Outcomes

Primary Outcome Measures

Weight-bearing (WB) ability and WB symmetry

Secondary Outcome Measures

Walking speed using the 10 meter-walk test (10MWT)
Dynamic balance control using the Timed up and go test (TUGT)

Full Information

First Posted
March 10, 2019
Last Updated
April 15, 2022
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT04192240
Brief Title
Weight-bearing Training in Stroke Patients.
Official Title
Immediate Effects of Lower Limb Loading Training During Sit-to-stand and Stepping With and Without External Feedback in Ambulatory Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 19, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

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

5. Study Description

Brief Summary
1. Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke? 1. Are there differences in mobility immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?
Detailed Description
Subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. Most of them will be recruited from a tertiary rehabilitation center and communities. Subjects have to participate in STS and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of WB ability during STS and stepping, walking speed, and balance ability. The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes were walking speed and balance ability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cerebrovascular disease, rehabilitation, walking, balance, mobility

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
WB Training with external feedback
Arm Type
Experimental
Arm Description
WB during sit-to-stand with external feedback for 10 minute and then, WB during stepping training with external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes.
Arm Title
WB Training without external feedback
Arm Type
Active Comparator
Arm Description
WB during sit-to-stand without external feedback for 10 minute and then, WB during stepping training without external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes.
Intervention Type
Other
Intervention Name(s)
WB Training with external feedback
Intervention Description
WB during sit-to-stand and stepping with external feedback, follow by overground walking.
Intervention Type
Other
Intervention Name(s)
WB Training without external feedback
Intervention Description
WB during sit-to-stand and stepping without external feedback, follow by overground walking.
Primary Outcome Measure Information:
Title
Weight-bearing (WB) ability and WB symmetry
Time Frame
Prior to and immediately after complete training program in one session
Secondary Outcome Measure Information:
Title
Walking speed using the 10 meter-walk test (10MWT)
Time Frame
Prior to and immediately after complete training program in one session
Title
Dynamic balance control using the Timed up and go test (TUGT)
Time Frame
Prior to and immediately after complete training program in one session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months) Age at least 40 years to 74 years Body mass index (BMI) between 18.5- 29.9 kg/m^2 Ability of independent walking over at least 10 meters with or without a walking device Ability to rise from a chair with or without using their arms Ability to follow a command used in the study Exclusion Criteria: any conditions that may affect ambulatory ability or ability to participate in the study, such as Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS) Deformity in the limbs or spine that affect ambulatory ability Modified Ashworth Scale (MAS) more 2 score Unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sugalya Amatachaya
Organizational Affiliation
School of physical therapy, Faculty of Associated medical sciences, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Associated Medical Science
City
Nai Muang
State/Province
KhonKaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26004813
Citation
Boukadida A, Piotte F, Dehail P, Nadeau S. Determinants of sit-to-stand tasks in individuals with hemiparesis post stroke: A review. Ann Phys Rehabil Med. 2015 Jun;58(3):167-72. doi: 10.1016/j.rehab.2015.04.007. Epub 2015 May 23.
Results Reference
result
PubMed Identifier
16139747
Citation
Lomaglio MJ, Eng JJ. Muscle strength and weight-bearing symmetry relate to sit-to-stand performance in individuals with stroke. Gait Posture. 2005 Oct;22(2):126-31. doi: 10.1016/j.gaitpost.2004.08.002.
Results Reference
result
PubMed Identifier
26957733
Citation
Park GD, Choi JU, Kim YM. The effects of multidirectional stepping training on balance, gait ability, and falls efficacy following stroke. J Phys Ther Sci. 2016 Jan;28(1):82-6. doi: 10.1589/jpts.28.82. Epub 2016 Jan 30.
Results Reference
result
PubMed Identifier
22306625
Citation
Tsaklis PV, Grooten WJ, Franzen E. Effects of weight-shift training on balance control and weight distribution in chronic stroke: a pilot study. Top Stroke Rehabil. 2012 Jan-Feb;19(1):23-31. doi: 10.1310/tsr1901-23.
Results Reference
result

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Weight-bearing Training in Stroke Patients.

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