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

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735148
• Other study ID #: A-23
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: March 1, 2017
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Cerebral Stroke
• Cerebrovascular Accident
• Cerebrovascular Stroke
• Stroke

Intervention

Other:
• Body Weight Supported Treadmill Training
There were three intervention arms in this study, Body Weight Supported Treadmill Training, Conventional Training and Combined Training.

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training Hospital	Istanbul
Turkey	Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale (BBS)	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
Primary	Single Leg Stance Test (SLST)	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
Primary	Timed Up and Go Test (TUG)	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
Primary	The Falls Efficacy Scale-International (FES-I)	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	Rivermead Mobility Index (RMI)	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
Secondary	The Comfortable and the Fast Gait Speed tests (CGS and FGS)	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
Secondary	The Stair Climbing ascend and descend tests (SCas and SCde)	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