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Clinical Trials/NCT05945966
NCT05945966
Completed
Not Applicable

Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients

Riphah International University1 site in 1 country32 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Riphah International University
Enrollment
32
Locations
1
Primary Endpoint
Functional reach test (FRT):
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

To determine the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients

Detailed Description

The aim of this study is to compare the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients. The randomized controlled trial will recruit the stroke patients will be selected and randomly divided into two groups: Group A (unilateral training group (UTG)) and Group B (bilateral training group (BTG)). Patients in Group A will undergo approach-oriented training using the motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the affected side, while those in Group B underwent strength training for the lower-limb muscles using Delorme's principle for the unaffected side and approach-oriented training using the MRP and PNF for the affected side for a period of six weeks, five days per week. A strengthening regimen will designed for the unaffected side, considering the frequency, intensity, time, and type (FITTs) principle provided by the American College of Sports Medicine (ACSM). The static and dynamic balance along with gait parameters will measure using the functional reach test (FRT), one-leg stance test (OLST), Berg balance scale (BBS) Dynamic Gait Index (DGI), gait parameters (stride length, gait velocity, and cadence), and Brunnstrom recovery stages (BRS) at the baseline and post rehabilitation.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
September 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Medically stable patients (the diagnosis was made by neurologist).
  • Cognitive level is greater than 25 on MMSE.
  • Chronic stroke Patients (ischemic and hemorrhagic) (6 months to 2 years).

Exclusion Criteria

  • Transient ischemic attack.
  • Patients with other neurological condition, orthopedic problems, and uncontrolled metabolic disease.
  • Severe hearing and visual loss.
  • Uncontrolled arterial hypertension.
  • Recurrent Stroke.
  • Patient diagnosed with brainstem stroke and middle cerebral artery stroke.
  • Patient with any cardiovascular unstable condition.

Outcomes

Primary Outcomes

Functional reach test (FRT):

Time Frame: 9 months

Functional reach test (FRT): It is clinical outcome measure tool for ascertaining dynamic balance in one task. It is performed with the participants in standing. It is the measure of the difference, in centimeters, between arm's length with arm at 90 degree flexion and maximum forward reach using a fixed base of support. It has 100% reliability and 76% sensitivity

Dynamic gait index (DGI):

Time Frame: 9 months

Dynamic gait index (DGI): The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls. It has high validity and reliability.

Berg balance scale (BBS):

Time Frame: 9 months

Berg balance scale (BBS): The Berg Balance Scale (BBS) is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. Its reliability is 0.98

Study Sites (1)

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