Weight-bearing Training in Stroke Patients.

April 15, 2022 updated by: Sugalya Amatachaya, Khon Kaen University

Immediate Effects of Lower Limb Loading Training During Sit-to-stand and Stepping With and Without External Feedback in Ambulatory Individuals With Stroke

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • KhonKaen
      • Nai Muang, KhonKaen, Thailand, 40002
        • Faculty of Associated Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WB Training with external feedback
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.
Other: WB Training with external feedback
WB during sit-to-stand and stepping with external feedback, follow by overground walking.
Active Comparator: WB Training without external feedback
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.
Other: WB Training without external feedback
WB during sit-to-stand and stepping without external feedback, follow by overground walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight-bearing (WB) ability and WB symmetry
Time Frame: Prior to and immediately after complete training program in one session
Prior to and immediately after complete training program in one session

Secondary Outcome Measures

Outcome Measure
Time Frame
Walking speed using the 10 meter-walk test (10MWT)
Time Frame: Prior to and immediately after complete training program in one session
Prior to and immediately after complete training program in one session
Dynamic balance control using the Timed up and go test (TUGT)
Time Frame: Prior to and immediately after complete training program in one session
Prior to and immediately after complete training program in one session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Sugalya Amatachaya, School of physical therapy, Faculty of Associated medical sciences, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

October 19, 2020

Study Completion (Actual)

October 25, 2020

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSD60I0015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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