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CompletedNCT05945966Updated Oct 12, 2023

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

An interventional study of Unilateral training group (UTG) and Bilateral training group (BTG). in Stroke, Ischemic, Balance; Distorted and Gait, Hemiplegic, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stroke, Ischemic
  • Balance; Distorted
  • Gait, Hemiplegic

Keywords

  • Stroke, Ischemic
  • Balance; Distorted
  • Gait, Hemiplegic
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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)

  • 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).

Interventions

  • OtherUnilateral 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

  • OtherBilateral 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 months

  2. 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.

    Time frame: 9 months

  3. 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

    Time frame: 9 months

07

Study locations

1 site
  • Riphah International University
    Islamabad, Fedral 44000, Pakistan
08

References and documents

Publications

  • 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. PubMed 32482912 ↗
  • 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. PubMed 34311607 ↗
  • 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. PubMed 32891079 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05945966
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Nov 1, 2022
Primary completion
Sep 1, 2023
Completion
Sep 15, 2023
Last update
Oct 12, 2023

Study contacts

Zeest Hashmi, MSNMPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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