The Effect of Body Weight Support Treadmill Training on Lower Limb Function in Patients With Chronic Stroke

NCT04491162 | Completed

• 1 other identifier: INK/ Rehab/ BWS/2016
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Gait Disorder, Sensorimotor

Keywords

Rehabilitation; Body weight supported treadmill training

Outcome Measures

Primary Outcomes (1)

• 10 meter walk test

  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 Outcomes (3)

• Cadence

  Two weeks

• Timed up and go test

  Two weeks

• Berg Balance Scale

  Two weeks

Study Arms (2)

Conventional gait therapy

ACTIVE COMPARATOR

Conventional gait therapy.

Other: Conventional therapy

BWST training

EXPERIMENTAL

Conventional gait therapy + Body weight support treadmill training

Other: Body weight support treadmill training + conventional therapy

Interventions

Body weight support treadmill training + conventional therapy OTHER

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.

BWST training

Conventional therapy OTHER

Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.

Conventional gait therapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

Institute of Neurosciences Kolkata

Kolkata, West Bengal, 700017, India

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

• Madhusree Sengupta, MD, PDF

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The observer was not allowed to know the treatment allocation. The patients were instructed not to discuss anything regarding his/ her treatment allocation with the examining investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: July 29, 2020
• Study Start: January 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)