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

U

University of Lahore

Status

Completed

Conditions

Gait, Drop Foot
Stroke
Hemiplegia
Pain
Foot Drop

Treatments

Combination Product: Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)
Combination Product: Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06539247
Rec-UOL-/200/08/24

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 2 patient groups

Motor Relearning Approach with EMS (MRA + EMS)
Experimental group
Description:
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)
Treatment:
Combination Product: Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS)
Proprioceptive Neuromuscular Facilitation with EMS (PNF + EMS)
Experimental group
Description:
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)
Treatment:
Combination Product: Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)

Trial contacts and locations

1

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Central trial contact

Hamna Sarfraz, MSPTN

Data sourced from clinicaltrials.gov

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