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

NCT05945966 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0210
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke, Ischemic; Balance; Distorted; Gait, Hemiplegic

Keywords

Stroke, Ischemic; Balance; Distorted; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (3)

• 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

  9 months

• 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.

  9 months

• 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

  9 months

Study Arms (2)

experimental group

EXPERIMENTAL

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)

control group

ACTIVE COMPARATOR

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

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

experimental group

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

control group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 32482912 BACKGROUND

• 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.

  PMID: 34311607 BACKGROUND

• 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.

  PMID: 32891079 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeest Hashmi, MSNMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: November 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)