- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491162
The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke
Stroke has severe debilitating neurological consequences for the victim. Within context of this study, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. Gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Due to this reason, recovery in gait ability of stroke patients is considered as a very important goal in rehabilitation.
Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait restoration after stroke. The present study focused on the possibility of BWSTT as a special program for improving gait ability. The purpose of this study was to evaluate the effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is thought to be a serious health problem which can cause severe disabilities. Aspects of disabilities caused by stroke are various according to the affected region and its severity. In general, sensory deficits, cognitive problem, motor impairment, visual perceptual disorders and dysphagia mainly occur among stroke patients. In particular, gait disturbance is induced by disabilities in muscle weakness, abnormal muscle contraction, or postural control. This gait disturbance is exhibited as an asymmetric gait pattern, such as a decrease in paretic side stance phase and non-paretic swing phase, cadence, velocity and difference in step length and stride length. Therefore, these differences create abnormal gait patterns in stroke patients. Furthermore, gait disturbance has an unfavorable effect on functional independence and prognosis of patients. Due to this reason, recovery in gait ability of stroke patients is considered as a very important goal in rehabilitation.
Gait performance is an indicator of mobility impairment and disability after stroke. It predicts mortality, morbidity, and risk of future stroke. Gait speed is responsive to short-term rehabilitation. An improvement in gait speed of 0.16 m/s can reduce the level of assistance in patients with subacute stroke and was recommended to be the minimum clinically significant difference. The control of gait involves the planning and execution from multiple cortical areas, such as secondary and premotor cortex. Stroke patients often have gait impairment such as decreased gait speed and asymmetrical gait cycle as a result of cortical reorganization. Repetitive mass motor task practice had been shown to facilitate neuroplasticity and brain reorganization in stroke patients, resulting in enhanced motor recovery after stroke.
Body weight supported treadmill training (BWSTT) is a task-oriented technique for gait restoration after stroke. BWSTT has the advantage over conventional therapy as it offers higher intensity, more repetitive and task-oriented practice over the same period of time when compared to conventional therapy. Several studies have showed that BWSTT was more effective in gait speed improvement than regular physiotherapy. It has been demonstrated that BWSTT induces changes in corticomotor excitability which lead to improved balance and gait performance with chronic stroke. However, other studies have reported that BWSTT was not superior to conventional gait training.
Recent studies have reported that BWSTT can increase walking endurance in the subacute stage after stroke, but no improvement was reported in balance and 10 m gait speed. To date, there are very few studies that have used gait analysis to show how the improvements in gait parameters come about after BWSTT or conventional therapy. There is still a lack of basic understanding of gait training on human locomotion.
Despite substantial recovery of independent ambulation by survivors following unilateral stroke, persistent gait abnormalities are observed in a large percentage of these persons. In these circumstances, a short-term intermittent and intensive rehabilitation program for chronic stroke survivors is thought to be particularly efficient for shoring up their independence, and the present study focused on the possibility of BWSTT as a special program for improving gait ability. The purpose of this study was to evaluate the effectiveness of a BWSTT intervention useful as a short-term intensive program for chronic stroke survivors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
West Bengal
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Kolkata, West Bengal, India, 700017
- Institute of Neurosciences Kolkata
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Age between 18 and 69 years, both genders will be acceptable.
- First episode of supratentorial stroke in hemiparesis (both ischaemic and haemorrhagic strokes)
- After 6 month from onset of stroke.
- All subjects were ambulatory before stroke
- Able to understand and follow simple verbal instruction, scoring at least 24 out of 30 on Mini Mental State Examination.
- Able to walk at least 10 meters distance independently, with or without a walking aids.
- Walking speed<0.75m/s at their self-selected velocity (SSV).
- Scoring 3 or 4 in Functional Ambulation Category Scale.
- Scoring less than 21 out of 23 on trunk Impairment Scale.
- Currently not receiving any other type of physiotherapeutic intervention.
Exclusion criteria
- Neurological disease affecting balance other than stroke.
- History of diagnosed musculoskeletal disorder of the trunk and / or lower extremities affecting the motor performance.
- History of Cerebrovascular accident more than one time or bilateral CVA at a time.
- Myocardial infarction within the past 6 months.
- Angina or ischemia at rest or during exercise.
- Unstable hypertension (>150/90 mmHg), arrhythmia, congestive heart failure or unstable cardio vascular status.
- Absence of active movement in the paretic lower limbs.
- Disability of joint including hip fracture and severe cardio pulmonary disease.
Study Plan
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 |
---|---|
Active Comparator: Conventional gait therapy
Conventional gait therapy.
|
Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
|
Experimental: BWST training
Conventional gait therapy + Body weight support treadmill training
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Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts. Patients in intervention arm were additionally trained with a 40% body weight support and a comfortable walking speed on treadmill for twenty minutes. The training, which was conducted three times a week, for period of two weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10 meter walk test
Time Frame: Two weeks
|
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
It can be employed to determine functional mobility, gait, and vestibular function.
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cadence
Time Frame: Two weeks
|
Cadence is measured as number of steps per minute during a 10 metre walk.
|
Two weeks
|
Timed up and go test
Time Frame: Two weeks
|
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. |
Two weeks
|
Berg Balance Scale
Time Frame: Two weeks
|
It is a widely used clinical test for static and dynamic balance.
It comprises of 14 balance related tasks.
A score of less than 20 signifies wheelchair use; 20-40: walking with assistance; 40-56: Independent ambulator.
|
Two weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Madhusree Sengupta, MD, PDF, Consultant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INK/ Rehab/ BWS/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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