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

Primary Purpose

Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Unilateral training group (UTG)
Bilateral training group (BTG).
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Functional reach test (FRT):
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):
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):
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

Secondary Outcome Measures

Full Information

First Posted
July 7, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05945966
Brief Title
Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients
Official Title
Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic
Keywords
Stroke, Ischemic, Balance; Distorted, Gait, Hemiplegic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Unilateral training group (UTG)
Intervention Description
stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side
Intervention Type
Other
Intervention Name(s)
Bilateral training group (BTG).
Intervention Description
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 Measure Information:
Title
Functional reach test (FRT):
Description
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
Time Frame
9 months
Title
Dynamic gait index (DGI):
Description
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.
Time Frame
9 months
Title
Berg balance scale (BBS):
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeest Hashmi, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32482912
Citation
Wang CY, Miyoshi S, Chen CH, Lee KC, Chang LC, Chung JH, Shi HY. Walking ability and functional status after post-acute care for stroke rehabilitation in different age groups: a prospective study based on propensity score matching. Aging (Albany NY). 2020 Jun 1;12(11):10704-10714. doi: 10.18632/aging.103288. Epub 2020 Jun 1.
Results Reference
background
PubMed Identifier
34311607
Citation
Stoykov ME, Heidle C, Kang S, Lodesky L, Maccary LE, Madhavan S. Sensory-Based Priming for Upper Extremity Hemiparesis After Stroke: A Scoping Review. OTJR (Thorofare N J). 2022 Jan;42(1):65-78. doi: 10.1177/15394492211032606. Epub 2021 Jul 26.
Results Reference
background
PubMed Identifier
32891079
Citation
Park C, Son H, Yeo B. The effects of lower extremity cross-training on gait and balance in stroke patients: a double-blinded randomized controlled trial. Eur J Phys Rehabil Med. 2021 Feb;57(1):4-12. doi: 10.23736/S1973-9087.20.06183-3. Epub 2020 Sep 6.
Results Reference
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Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients

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