Clinical trial NCT06407830: Effect of MRP With and Without EMS on Gait, Functional Independence and QOL in Stroke Patients
Official title: Effects of Motor Relearning Program With and Without Electrical Muscle Stimulation on Gait, Functional Independence and Quality of Life in Hemiplegic Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Gait
Functional independence
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 66
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of motor relearning programme with and without electrical muscle stimulation on gait, functional independence and quality of life in hemiplegic stroke patients.

Detailed description: A study was performed a motor relearning program in stroke survivors. A clinically significant improvement was found in the motor relearning groups, and only in one study is this improvement significant compared to another intervention.

Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post-Stroke. While the potential for enhancing functional motor ability seems less clear, the current systematic review and meta analysis's results point to a significant positive impact of NMES on ADL function during the post stroke rehabilitation process.

People with hemiparesis who received both conventional treatment and interventions based on motor relearning showed a significant improvement in their level of disability. There were no appreciable gains in the HRQoL perception.

Many research investigations have been carried out to assess the effects of motor relearning programs with regard to specific functional aspects and physical deficiencies. Up to the researcher's knowledge, there is no data to assess the effects of electrical muscle stimulation along with motor relearning programs in stroke patients. Therefore, the purpose of this study is to compare how a motor relearning program with and without electrical muscle stimulation affects hemiplegic stroke patients' gait, level of functional independence, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as hemiplegic stroke

  * Age between 45-65 years
  * Both males and females
  * Mini-Mental State Examination score ≥24
  * Able to stand independently for at least 1 min and (5) can ambulate 25 feet/10 m (with or without the assistive device)

Exclusion Criteria:

* Experiencing balance problems as a result of neurological conditions other than stroke (for instance cerebellar impairment, inner ear dysfunction, or Parkinson's disease)

  * Fixed ankle or foot contracture.
  * A serious cardiac disease (aorta stenosis, angina, hypertrophic cardiomyopathy, arrhythmia and pacemakers).
  * congenital limb deformities

Primary outcomes:
measure: Functional Independence Measurement (FIM).
timeFrame: baseline week 1 and post interventional week 8
Secondary outcomes:
measure: Dynamic Gait Index
timeFrame: baseline week 1 and post interventional week 8
measure: Stroke specific quality of life
timeFrame: baseline week 1 and post interventional week 8
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University (Lahore)
name: Aruba Saeed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghrouz A, Marco E, Munoz-Redondo E, Boza R, Ramirez-Fuentes C, Duarte E. The effect of motor relearning on balance, mobility and performance of activities of daily living among post-stroke patients: Study protocol for a randomised controlled trial. Eur Stroke J. 2022 Mar;7(1):76-84. doi: 10.1177/23969873211061027. Epub 2022 Feb 11.
citation: Paolucci T, Agostini F, Mussomeli E, Cazzolla S, Conti M, Sarno F, Bernetti A, Paoloni M, Mangone M. A rehabilitative approach beyond the acute stroke event: a scoping review about functional recovery perspectives in the chronic hemiplegic patient. Front Neurol. 2023 Sep 15;14:1234205. doi: 10.3389/fneur.2023.1234205. eCollection 2023.
citation: Mesci N, Ozdemir F, Kabayel DD, Tokuc B. The effects of neuromuscular electrical stimulation on clinical improvement in hemiplegic lower extremity rehabilitation in chronic stroke: a single-blind, randomised, controlled trial. Disabil Rehabil. 2009;31(24):2047-54. doi: 10.3109/09638280902893626.