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Completed

NCT Number: NCT05945966

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

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

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Key information

Conditions

Stroke, Ischemic Balance; Distorted Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Ischemic Stroke Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Islamabad, Fedral, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unilateral training group (UTG)

Other

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

Bilateral training group (BTG).

Other

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 outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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