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

Not Applicable

Completed

• Conditions: Stroke, Ischemic; Gait, Hemiplegic; Balance; Distorted
• Interventions: Other: Unilateral training group (UTG); Other: Bilateral training group (BTG).

• Registration Number: NCT05945966
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-14
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Unilateral training group (UTG)	In this group stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side
control group	Bilateral training group (BTG).	In this group stroke patients will be undergone strength training using frequency, intensity, type, time (FITT) principle to non-hemi-paretic side and task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) to hemi-paretic side

Primary Outcome Measures

Name	Time	Method
Functional reach test (FRT):	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):	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):	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

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Islamabad, Fedral, Pakistan