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Clinical Trials/CTRI/2018/12/016685
CTRI/2018/12/016685Not yet recruitingPhase 1

Effect of structured strength training of unaffected lower limb on balance and gait among stroke subjects-A Non Randomized Trial

Manipal Academy of Higher Education1 site in 1 country28 target enrollmentStarted: December 16, 2018Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
28
Locations
1
Primary Endpoint
Balance

Study Overview

Brief Summary

Diagnosed stroke subjects, referred by Neurologists to the Department of Physiotherapy will be approached . Informed consent will be taken from willing subjects. The purpose of the study will be explained.Subjects will be screened based on inclusion and exclusion criteria.  Demographic and baseline data will be collected through hand held dynamometer, Brunel Balance Scale. Wisconsin Gait Scale and Videography.

A camera mounted on tripod stand with spirit level will be kept at 4 meters perpendicular distance from the midpoint of walkway with the height of the camera corresponding to the level of knee joint. Duct tapes will be used to mark the specified distance. Reflective markers will be applied on greater trochanter, lateral condyle of femur, medial malleolus of fibula and head of fifth metatarsal. The subject will be made to ambulate 5 meter distances with or without support according to the subject’s ability and the video will be recorded by GoPro Hero camera. Video analysis of each will be done using Kinovea video analysis software by freezing each stance phase of gait cycle and following things will be measured:

  1. Degree of flexion of the hip.

  2. Degree of hyperextension of knee .

  3. Degree of ankle dorsiflexion.

  4. Total time taken to complete the distance.

the subjects will be allocated in two groups.

A structured strength training of the unaffected lower limb with conventional rehabilitation will given to one group and other group will be receiving conventional rehabilitation.

12 sessions post intervention outcome measurements will be collected.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Clinically stable, single episode of diagnosed case of stroke referred by the Neurologist and Physician.
  • •Ability to understand and follow instructions with MMSE score more than or equal to
  • •Ability to walk 5 metes with or without assistive device.

Exclusion Criteria

  • •Stroke Subjects having concurrent neurological disorders like Alzheimer’s, Parkinson etc.
  • •An unstable hypertension or cardiovascular condition, as determined by a physician which may affect the performance.
  • •Any musculoskeletal disorder which may affect the performance.
  • •Infra-tentorial stroke.
  • •Pusher’s syndrome or other perceptual deficits.
  • •Severe visual field deficits.

Outcomes

Primary Outcomes

Balance

Time Frame: Pre-intervention | post intervention (2 weeks)

Observational Gait Analysis

Time Frame: Pre-intervention | post intervention (2 weeks)

Secondary Outcomes

  • Lower Limb Muscle Strength(Pre-intervention)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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