The Effects of Body Weight Supported Treadmill Training On Balance In Stroke Patients

March 1, 2017 updated by: RUSTEM MUSTAFAOGLU, Istanbul University

The Effects of Body Weight Supported Treadmill Training On Static And Dynamic Balance In Stroke Patients: A Randomized-Single Blind Study

Stroke is one of the most common causes of acquired adult disability. The majority of stroke survivors have mobility difficulties such as poor standing, decreased walking speed, balance disturbances, and increased risk for falls. Improving mobility, functional walking and balance are the main goals of stroke rehabilitation. Robotic technologies are becoming more promising intervention for the locomotor training in stroke rehabilitation. Static or dynamic balance deficits act crucial role on gait performance among stroke survivors. Therefore it is important to determine the effects of BWSTT in improving balance in persons with stroke. Although it has been demonstrated that BWSTT improved balance and gait performance in stroke patients, it is not clear whether the improvements are greater compared with those associated with other gait rehabilitation methods. To the investigators knowledge, there are also limited studies in the literature concerning the effects of BWSTT on falling risk in stroke patients. The strong evidence is needed about the effectiveness of BWSTT including comprehensive determinants of balance with combined and isolated intervention groups.This study aims to compare the effects of BWSTT with combined and isolated intervention on balance, gait and fall risk in patients with subacute and chronic stroke. The investigators hypotheses are that after stroke:

  1. the combination of BWSTT with conventional training may lead to more improved balance parameters;
  2. when applied as an isolated intervention, BWSTT or conventional training may lead to similar results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants:

All participants with stroke were recruited from a government rehabilitation hospital between November 2014 and November 2015. All treatments were performed in the same hospital.

Sample Size:

"Power and Sample Size Program" was used to calculate sample size. It was determined by considering a previous study which calculated minimal detectable change of Berg Balance Scale (BBS) for stroke patients(20). According to this study to the response within each subject group was normally distributed with standard deviation 7.87 and minimal detectable change was found 10% for BBS. It was calculated that 15 participants were needed in each group with probability (power) 0.8 and 0.016 alpha level computed by Bonferroni adjustment.

Procedure:

One hundred and seven stroke patient were assessed for eligibility by two physiatrists (B.E and B.G). Forty-two (13 women, range of age: 18-75 years) patients were found to be suitable for inclusion criteria of the study. Randomisation was performed by using randomisation function of Microsoft Office Excel programme by another researcher (ARO). Random number generator of Microsoft Office Excel Software gave a random number between 0 and 1 to the each treatment columns which were created by ARO. Sorting the random number row from the largest to the smallest number was performed by the sort and filter menu. Treatment assignments were stratified according to the severity of impairment at baseline and the study site to ensure balanced distribution among the three groups.After the randomisation,assessments at baseline and after training were performed by two physiotherapists who were blind to the interventions (IY, BEH). All the participants were treated in the rehabilitation hospital by a physiotherapist who was experienced in stroke rehabilitation. BWSTT Training was performed by RM.

Study Type

Interventional

Enrollment (Actual)

45

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

  • Turkey
      • Istanbul, Turkey
        • Istanbul Physical Medicine and Rehabilitation Training Hospital
      • Istanbul, Turkey
        • Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stroke onset at least 3 months before the study
  • being 18-75 years old
  • to be able to walk 10 meter independently or under supervision
  • to be able to walk independently with or without ankle-foot-orthosis
  • to be able to understand all instructions during treatment sessions

Exclusion Criteria:

  • previously having stroke
  • having other health conditions which prevent walking
  • having contracture or range of motion limitation in lower extremity which affect walking
  • having uncontrolled hypertension
  • severe cognitive impairment

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional Training
Conventional training sessions generally consisted of exercises which aimed to improve range of motion, strength, and movement quality in upper and lower extremity as an in-patient rehabilitation protocol. Also developing static and dynamic postural control and increasing walking distance were the other aims of training. Duration of the Conventional Training is 45 minute per session, 3 days a week for 6 weeks.
Experimental: Body Weight Supported Treadmill Training

Body weight supported treadmill training (BWSTT) was composed of outpatients who were undertaken only BWST training with 45-minute sessions, 2 days a week during 6 weeks.

BWST Training

Locomat (Hocoma) was used in BWSTT group with 20 % body weight reduced. The participants walked on device at 1.8 km/h (0.5 m/sec) velocity. For each participant body weight portion was ensured by a security belt while walking. Each session took 45 minutes including setup, commands and rest time. Verbal instructions were used for encouragement but no manual assistance was given to improve gait pattern.
Other: Body Weight Supported Treadmill Training

There were three intervention arms in this study,

  1. Body Weight Supported Treadmill Training,
  2. Conventional Training and
  3. Combined Training.
No Intervention: Combined Training
Combined Training consisted of inpatient participants who were treated with 45 minute-conventional training, 5 days a week during 6 weeks. Additionally this group had 45 minute-BWST training, 2 days a week during 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: 6 weeks
This 14-item objective measure was used to assess postural control and balance of the participants. Item-level scores of BBS range from 0-4; summed score of the items were used in this study. Higher score indicates better mobility performance.
6 weeks
Single Leg Stance Test (SLST)
Time Frame: 6 weeks
SLST was performed with eyes open while resting the arms on the hips. The participant stand on one leg with this position and timed in seconds from time one foot is flexed to time when s/he touched the ground, jumped or touched anything to support was calculated by the physiotherapist three times. After three trials the average of the three trials was recorded. Shortening the time to stand on one leg was a marker for decreased balance function.
6 weeks
Timed Up and Go Test (TUG)
Time Frame: 6 weeks
TUG is a reliable and simple test to assess balance and functional mobility of stroke patients. The patient sited in chair and with command of physiotherapist raised from the chair, walked 3 meters, walked back to the chair and sited down again. The time of process was recorded by the physiotherapist in seconds. It was allowed to use walking aid during the test. Lower duration indicates better mobility performance.
6 weeks
The Falls Efficacy Scale-International (FES-I)
Time Frame: 6 weeks
FES-I was used to assessed the anxiety level of participants about falling while performing activities indoor or outdoor. It has 16 items scored on a 4-point Likert scale. We used Turkish version of FES-I in our study. Higher score indicates better mobility performance.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rivermead Mobility Index (RMI)
Time Frame: 6 weeks
RMI was used to assess functional mobility of the patients. In this 15-item test, the items about mobility progress in difficulty including rolling in bed to running. Items are coded as either 0 or 1 depending on whether the patient can complete the task. Total score are determined by summing the points. Higher score indicates better mobility performance.
6 weeks
The Comfortable and the Fast Gait Speed tests (CGS and FGS)
Time Frame: 6 weeks
The Comfortable and the Fast Gait Speed tests (CGS and FGS)was used to determine the speed of walking. The test was applied in a corridor between two chairs which were placed 14 meters apart. 0, 2nd, 12th and 14th meters were determined. The patients were wanted to walk comfort and allowed to use walking aid. At 2nd meter the stopwatch was started and stopped when the patient reached the 12th meter. The time of process was recorded by the physiotherapist in seconds. Lower duration indicates better mobility performance.
6 weeks
The Stair Climbing ascend and descend tests (SCas and SCde)
Time Frame: 6 weeks
Duration of ascending and descending 10 steps was measured in seconds with a stopwatch. Step height of the stair was 20 cm. The participants did not allowed to get support from latter bar. The time of process was recorded by the physiotherapist in seconds.After three trials the average of the three trials was recorded. Lower duration indicates better mobility performance.
6 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Study Director: IPEK YELDAN, Assoc.prof, Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

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

November 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-23

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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