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Completed

NCT Number: NCT06539247

MRP Verses 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS)

Combination Product

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.

Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)

Combination Product

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.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Acronym: CEMRA-PNF

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Dec 24, 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.

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