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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407830
• Other study ID #: REC/RCR&AHS/23/0278
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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 muscle during the session.

Locations

Country	Name	City	State
Pakistan	Rehabilitation Center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dynamic Gait Index	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.	baseline week 1 and post interventional week 8
Secondary	Stroke specific quality of life	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.	baseline week 1 and post interventional week 8