Stepping Training Using Feedback in Stroke

March 8, 2019 updated by: Sugalya Amatachaya, Khon Kaen University

Effects of Stepping Training With and Without the Use of Visually Weight-taking Machine (VWTM) on Walking and Balance Ability in Patients With Stroke

  • Are there differences in immediate effects of stepping training with and without the use of visually weight-taking machine (VWTM) on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?
  • Are there differences of 4-week stepping training with and without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?

Study Overview

Status

Completed

Detailed Description

  • To compare immediate effects of stepping training with or without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke.
  • To compare effects of 4-week stepping training with or without the use of VWTM on variables relating to well-controlled walking and walking symmetry in patients with stroke.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

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

45 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects are independent ambulatory patients with first stroke episode with the age at least 45-74 years old,
  • subacute (post-stroke time < 6 months) or chronic (post-stroke time ≥ 6 months) stroke
  • Independent walking at least 10 meters with or without a walking device
  • Able to follow verbal command used in this study

Exclusion Criteria:

  • The subjects who have other medical conditions that might affect participation in the study such as uncontrolled underlying diseases (i.e. hypertension, heart disease, thyroid, etc.), deformity in the lower extremities, pain more than 5 out of 10 on a visual analog scale, legally blind or had a history of visual deficits that were unable to be corrected by glasses or contact lens, have a color blindness and inability to communicate or follow the commands used in this study

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stepping training with feedback
Subjects stand in a step standing position with placing the affected leg on the load cells of the VWTM and the non-affected leg slightly backward outside the load cells, look forward to light bars of the displayed section which will be set at their eye level. Then subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can. Subjects repetitively practice the task for 30 minutes with a period of sufficient rest as required.
Stepping training with the use of external feedback. The subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can.
NO_INTERVENTION: Stepping training without feedback
Subjects will be trained and instructed the same as the experimental group but without using the displayed section, for approximately 30 minutes/day (excluding rest periods), 5 days/week, for 4 week. Then, every subject will be trained to walk overground with or without a walking device for 10 minutes in order to promote transferability of the part-task practice to the whole/target task. Subjects still receive routine treatments from other rehabilitation professionals as needed during participation in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10MWT
Time Frame: 4 weeks
Walking speed
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6MWT
Time Frame: 4 weeks
Walking endurance
4 weeks
TUGT
Time Frame: 4 weeks
Balance and walking ability
4 weeks
Lower limb support ability
Time Frame: 4 weeks
% of bosy-weight on single leg during stepping
4 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sugalya Amatachay, Ph.D., School of Physical Therapy,Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

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)

April 10, 2016

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (ESTIMATE)

September 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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