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Recruiting NCT06407830

Effect of MRP With and Without EMS on Gait, Functional Independence and QOL in Stroke Patients

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: motor relearning programme, electrical muscle stimulations with motor relearning programme.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other motor relearning programme
    Treatment protocol includes Brief period of warm up and cool down (5 minutes). Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions of task specific training based on the motor relearning programme. Each task specific training consists of 10 minutes.
  • Other electrical muscle stimulations with motor relearning programme
    Treatment protocol includes Brief period of warm up and cool down (5 minutes). Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions of task specific training based on the motor relearning programme. Each task specific training consists of 10 minutes. Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions for 8 weeks task specific training based on the motor relearning programme and 10 minutes of the EMS of each

Primary outcome measures

  • Functional Independence Measurement (FIM). [Time frame: baseline week 1 and post interventional week 8]
Secondary outcome measures (2)
  • Dynamic Gait Index [Time frame: baseline week 1 and post interventional week 8]
  • Stroke specific quality of life [Time frame: baseline week 1 and post interventional week 8]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Rehabilitation Center — Lahore

Publications

  • 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. PMID 35300258
  • 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. PMID 37789885
  • 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. PMID 19874084

Identifiers

NCT: NCT06407830 · REC/RCR&AHS/23/0278

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗