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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05945966
Collaborator
(none)
32
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Unilateral training group (UTG)
  • Other: Bilateral training group (BTG).
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
patients will be allocated to intervention groups by randomization Patients in group A will be given MRP and PNF techniques to involve side Patients In group B will be given exercises same as above but on unaffected side.The strengthening exercises also given to this grouppatients will be allocated to intervention groups by randomization Patients in group A will be given MRP and PNF techniques to involve side Patients In group B will be given exercises same as above but on unaffected side.The strengthening exercises also given to this group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

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

Other: Unilateral training group (UTG)
stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side

Active Comparator: control group

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

Other: Bilateral training group (BTG).
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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riphah International University Islamabad Fedral Pakistan 44000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Zeest Hashmi, MSNMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05945966
Other Study ID Numbers:
  • REC/RCR & AHS/23/0210
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2023