MRP Verses PNF on Pain, Foot Drop, Gait and Functional Mobility in Hemiplegic Patients. (CEMRA-PNF)

December 19, 2024 updated by: Hamna Sarfraz, University of Lahore

Comparative Effects of Motor Relearning Approach Versus Proprioceptive Neuromuscular Facilitation Technique (PNF) on Pain, Foot Drop, Gait and Functional Mobility in Hemiplegic Patients

This single blinded randomized control study aimed to determine the comparative effectiveness of two rehabilitation approaches for improving pain, foot drop, gait, and functional mobility in patients with hemiplegia. The study recruited 68 patients diagnosed with hemiplegia who met specific inclusion criteria. Both groups received a treatment program lasting eight weeks, with assessments at baseline, week four, and week eight. The study measured various outcomes as gait analysis, foot drop grading, functional ability and pain assessment. This study aimed to contribute to evidence-based practice in stroke rehabilitation by comparing the effectiveness of motor relearning and PNF approaches for improving gait, pain, and functional mobility in hemiplegic patients. The findings may help guide therapists in selecting the most appropriate intervention for individual patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is a leading cause of disability worldwide, with hemiplegia (muscle weakness or paralysis on one side of the body) being a common consequence. Rehabilitation plays a crucial role in improving gait, reducing pain and enhancing functional mobility for stroke patients. This study investigated the comparative effects of two rehabilitation approaches: Motor Relearning (MRP) and Proprioceptive Neuromuscular Facilitation (PNF).

Study Design: This was a randomized controlled trial with two parallel groups:

Group A: Motor Relearning Approach with Electrical Muscle Stimulation (EMS) Group B: Proprioceptive Neuromuscular Facilitation Technique (PNF) with Electrical Muscle Stimulation (EMS)

Randomization: Eligible participants were randomly assigned to either group using a lottery method to ensure balance between groups.

Blinding: The assessor evaluating outcomes were blinded to group allocation (single-blinded).

Intervention: Both groups received an eight-week intervention program with assessments at baseline, week four, and week eight. Each session lasted approximately 30 minutes.

Group A (MRP with EMS): Participants performed motor relearning exercises targeting foot drop and gait patterns. EMS was integrated during specific exercises for targeted muscle activation.

Group B (PNF with EMS): Participants received PNF techniques designed to improve neuromuscular facilitation for gait and foot clearance. EMS was used alongside PNF exercises to enhance muscle response.

Outcome Measuring Tools:

Primary Outcomes: Dynamic Gait Index (DGI) for gait analysis and Manual Muscle Testing (MMT) test for foot drop grading Secondary Outcomes: Motor Assessment Scale to measure of functional ability and Numeric Pain Rating Scale (NPRS) for pain assessment.

Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.

Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54590
        • University of Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients having age between 45 to 65 years (Kagawa et al., 2013)
  • Hemiplegic, impaired functional mobility and dependent (Kanase, 2020)
  • Functional deficits in lower limb, with both the Sexes and any side (left or right) (Kanase, 2020)
  • Patients having hemiplegia within 6 months might be post-stroke, able to follow instructions (Kanase, 2020)
  • Diagnosed with hemiplegia having a stable neurological condition (e.g., stroke) (Anandan et al., 2020)
  • Minimum score of 12 on the Dynamic Gait Index (DGI) to ensure sufficient baseline gait function for meaningful comparison (Singha, 2017).
  • Grade 3 foot drop (Tibialis Anterior) on the Motor Assessment Scale in the affected leg to have room for improvement in both interventions (Singha, 2017).
  • Participants having moderate to severe pain of ≤ 4 (moderate) and ≥ 7 (severe) on numeric pain rating scale (NPRS) at rest , were included to minimize confounding effects of pain on gait and mobility (Beebe et al., 2021).
  • Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).

Exclusion Criteria:

  • Subjects having any medical condition that affects his/her performance (Kanase, 2020)
  • Completely recovered case of Hemiplegia in terms of walking abilities & upper limb activities (Kanase, 2020)
  • Subjects with Transient Ischemic Attack (Kanase, 2020)
  • Other neurological conditions such as severe cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motor Relearning Approach with EMS (MRA + EMS)

This arm received a 30-minute motor relearning program focused on improving foot drop and gait patterns. The program consisted of:

Motor Relearning Practice (20 minutes): Participants practiced walking, starting with individual components and gradually progressing to full walking sequences. The unaffected leg initiates each step, with the physiotherapist providing support as needed (Singh, 2017).

Electrical Muscle Stimulation (EMS) for Targeted Activation (10 minutes): EMS applied to the affected ankle dorsiflexors for 10 minutes to stimulate muscle activation. The parameters were:

Pulse amplitude: 40 mA (default) Pulse duration: adjusted to achieve balanced maximum ankle dorsiflexion Mode: adaptive, considering both intensity and duration for safe foot lift during walking Electrode placement: on the affected ankle dorsiflexors Intensity: set to a comfortable level for the participant (Knutson & Chae, 2010)
Combination product: Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS)
This arm received a 30-minute motor relearning program focused on improving foot drop and gait patterns and Electrical Muscle Stimulation (EMS) for Targeted Activation (10 minutes) with 40 mA (default) adaptive, considering both intensity and duration for safe foot lift during walking.
Experimental: Proprioceptive Neuromuscular Facilitation with EMS (PNF + EMS)

This arm received a 30-minute intervention combining Proprioceptive Neuromuscular Facilitation (PNF) techniques and EMS. The program consisted of:

PNF Techniques for Neuromuscular Facilitation (20 minutes) in side-lying position with the affected leg uppermost. The sequence involved rhythmic initiation movements, measured using an alarm clock (Singh, 2017).

Electrical Muscle Stimulation (EMS) for Muscle Response Enhancement (10 minutes): Similar to Arm 1, EMS applied to the affected ankle dorsiflexors for 10 minutes with the same parameters:

Pulse amplitude: 40 mA (default) Pulse duration: adjusted to achieve balanced maximum ankle dorsiflexion Mode: adaptive, considering both intensity and duration for safe foot lift during walking Electrode placement: on the affected ankle dorsiflexors Intensity: set to a comfortable level for the participant (Knutson & Chae, 2010)
Combination product: Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)

This arm received a 30-minute intervention combining Proprioceptive Neuromuscular Facilitation (PNF) techniques and EMS. The program consisted of:

PNF Techniques for Neuromuscular Facilitation (20 minutes) and Electrical Muscle Stimulation (EMS) for Muscle Response Enhancement (10 minutes): Similar to Arm 1, EMS applied to the affected ankle dorsiflexors for 10 minutes with the same parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait analysis
Time Frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
The Dynamic Gait Index was a standardized tool used to assess gait function in individuals with lower extremity impairments. It evaluated 8 components of gait, with higher scores indicating better gait quality. A total score below 19 suggests a higher risk of falls, whereas scores above 22 are associated with safe ambulation
8 weeks (baseline, fourth week and then at the end of the 8 week)
Foot Drop
Time Frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
Manual Muscle Testing was a standardized test that assessed muscle strength on a 5-point scale (0 = no contraction to 5 = normal strength). This was used specifically for the affected leg's dorsiflexor muscles (Tibialis Anterior).
8 weeks (baseline, fourth week and then at the end of the 8 week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ability
Time Frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
The Motor Assessment Scale is a clinical tool designed to evaluate functional abilities in stroke patients, focusing on everyday motor functions. The scale ranges from a minimum score of 0 (indicating inability to perform tasks) to a maximum score of 6 (indicating optimal performance across all tasks). Higher scores reflect greater functional independence, making it a valuable assessment for rehabilitation settings.
8 weeks (baseline, fourth week and then at the end of the 8 week)
Pain intensity
Time Frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
The Numeric Pain Rating Scale is a widely utilized tool for assessing pain intensity in adults. It operates on an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Higher scores on this scale signify greater pain intensity, making it a straightforward method for patients to communicate their pain levels to healthcare providers.
8 weeks (baseline, fourth week and then at the end of the 8 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Faiza Sharif, PHD, Associate professor
  • Study Director: Hira Riaz, MSOMPT, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2024

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

December 17, 2024

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rec-UOL-/200/08/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data was collected from the Sehat Medical Complex, Hanjarwal and University of Lahore Teaching Hospital, Lahore after taking informed written consent form through the questionnaires. A comparative analysis was conducted between Group A and Group B, evaluating improvements in MMT Grading , Dynamic Gait Index, Numeric Pain Rating Scale (NPRS) and Motor Assessment scale scores. The data was entered and analyzed using SPSS Version 24.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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