Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06407830

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Center

Lahore, Punjab Province, 54600, Pakistan

Location status: Recruiting

Location contact

Rashida Arshad, MSNMPT*

PRINCIPAL_INVESTIGATOR

wajiha shahid, PhD

CONTACT

[email protected]

03214885079

wajiha shahid, Phd

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Functional Independence Measurement (FIM).

    Time frame: baseline week 1 and post interventional week 8

    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.

Secondary outcomes

  1. Dynamic Gait Index

    Time frame: baseline week 1 and post interventional week 8

    The DGI has 8 items: walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score thus indicates greater impairment in functional mobility.

  2. Stroke specific quality of life

    Time frame: baseline week 1 and post interventional week 8

    The SSQOL is a valid, reliable measurement that assesses health-related quality of life in stroke subjects and consists of a 49-item scale (each scored 1-5) representing 12 domains, for a maximum score of 245. All subjects were assessed while not wearing the treatment device.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Motor Relearning Program With and Without Electrical Muscle Stimulation on Gait, Functional Independence and Quality of Life in Hemiplegic Stroke Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 9, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.