Clinical trial NCT05945966: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Balance; Distorted
Gait, Hemiplegic
Keywords: Stroke, Ischemic
Balance; Distorted
Gait, Hemiplegic
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional reach test (FRT):
timeFrame: 9 months
measure: Dynamic gait index (DGI):
timeFrame: 9 months
measure: Berg balance scale (BBS):
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Fedral
Study officials:
affiliation: Riphah International University
name: Zeest Hashmi, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.