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

NCT06407830 | Recruiting

• 1 other identifier: REC/RCR&AHS/23/0278
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Gait; Functional independence; Quality of life

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measurement (FIM).

  The Functional Independence Measure (FIM) instrument was applied to assess the changes in functional ability. Out of the eighteen items in the FIM, thirteen evaluate physical domains and five evaluate cognitive functions. Each item is scored from 1 to 7 ("1" total dependence; "7" complete independence). The final score ranges from 18 to 126.

  baseline week 1 and post interventional week 8

Secondary Outcomes (2)

• Dynamic Gait Index

  baseline week 1 and post interventional week 8

• Stroke specific quality of life

  baseline week 1 and post interventional week 8

Study Arms (2)

Intervention physical therapy

ACTIVE COMPARATOR

Motor Relearning programme training

Other: motor relearning programme

Electrical Muscle Stimulation

EXPERIMENTAL

Electrical Muscle Stimulation with Motor Relearning programme

Other: motor relearning programme; Other: electrical muscle stimulations with motor relearning programme

Interventions

motor relearning programme OTHER

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.

Electrical Muscle Stimulation; Intervention physical therapy

electrical muscle stimulations with motor relearning programme OTHER

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 muscle during the session.

Electrical Muscle Stimulation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rehabilitation Center

Lahore, Punjab Province, 54600, Pakistan

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aruba Saeed, PhD

  Riphah International University (Lahore)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)