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

NCT02735148 | Completed

• 1 other identifier: A-23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

Cerebrovascular Stroke; Cerebral Stroke; Cerebrovascular Accident

Keywords

Postural balance; Accidental falls; Rehabilitation; Cerebrovascular Accident; Walking; Mobility limitation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Rivermead Mobility Index (RMI)

  6 weeks

• The Comfortable and the Fast Gait Speed tests (CGS and FGS)

  6 weeks

• The Stair Climbing ascend and descend tests (SCas and SCde)

  6 weeks

Study Arms (3)

Conventional Training

NO INTERVENTION

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.

Body Weight Supported Treadmill Training

EXPERIMENTAL

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

Combined Training

NO INTERVENTION

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.

Interventions

Body Weight Supported Treadmill Training OTHER

There were three intervention arms in this study, 1. Body Weight Supported Treadmill Training, 2. Conventional Training and 3. Combined Training.

Body Weight Supported Treadmill Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

Istanbul Physical Medicine and Rehabilitation Training Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

Related Publications (32)

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MeSH Terms

Conditions

Stroke; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• IPEK YELDAN, Assoc.prof

  Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 12, 2016
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)