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CompletedNCT06539247CEMRA-PNFUpdated Dec 24, 2024

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

An interventional study of Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS) and Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS) in Stroke, Pain and Gait, Drop Foot, sponsored by University of Lahore. Completed at 1 site in Pakistan. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by University of Lahore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2024, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stroke
  • Pain
  • Gait, Drop Foot
  • Foot Drop
  • Hemiplegia

Keywords

  • Motor Relearning
  • Proprioceptive Neuromuscular Facilitation
  • Muscle Stimulation
  • Gait Analysis
  • Functional Mobility
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Lahore is the lead sponsor of 230 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • Combination productMotor 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.

  • Combination productProprioceptive 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.

06

What researchers measure

Primary outcomes

  1. Gait analysis

    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

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

  2. Foot Drop

    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).

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

Secondary outcomes

  1. Functional Ability

    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.

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

  2. Pain intensity

    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.

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

07

Study locations

1 site
  • University of Lahore
    Lahore, Punjab Province 54590, Pakistan
08

References and documents

Publications

  • Beebe JA, Kronman C, Mahmud F, Basch M, Hogan M, Li E, Ploski C, Simons LE. Gait Variability and Relationships With Fear, Avoidance, and Pain in Adolescents With Chronic Pain. Phys Ther. 2021 Apr 4;101(4):pzab012. doi: 10.1093/ptj/pzab012. PubMed 33482005 ↗
  • Kagawa S, Koyama T, Hosomi M, Takebayashi T, Hanada K, Hashimoto F, Domen K. Effects of constraint-induced movement therapy on spasticity in patients with hemiparesis after stroke. J Stroke Cerebrovasc Dis. 2013 May;22(4):364-70. doi: 10.1016/j.jstrokecerebrovasdis.2011.09.021. Epub 2011 Nov 10. PubMed 22078779 ↗
  • Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7. PubMed 20531158 ↗
  • Page SJ, Levine P, Leonard A. Mental practice in chronic stroke: results of a randomized, placebo-controlled trial. Stroke. 2007 Apr;38(4):1293-7. doi: 10.1161/01.STR.0000260205.67348.2b. Epub 2007 Mar 1. PubMed 17332444 ↗
  • Anandan, D., PK, T. N., Arun, B., & Priya, V. (2020). Effect of task specific training with proprioceptive neuromuscular facilitation on stroke survivors. Biomedicine, 40(3), 363-366.
  • Kanase, S. B. (2020). Effect of motor relearning programme and conventional training on functional mobility in post stroke patients. Indian Journal of Public Health Research & Development, 11(5), 496-501.
  • Singha, R. (2017). Motor Relearning Program versus Proprioceptive Neuro-Muscular Facilitation Technique for Improving Basic Mobility in Chronic Stroke Patients-A Comparative Study. Int J Physiother Res, 5(6), 2490-2500.

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Nov 2024, 9 months.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 9 months is below that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2024
First posted
Aug 6, 2024
StartActual
Jan 28, 2024
Primary completionActual
Nov 15, 2024
CompletionActual
Dec 17, 2024
Last update
Dec 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06539247
Responsible party
Hamna Sarfraz (Student, University of Lahore) — Principal investigator
First posted
Aug 6, 2024
Start date
Jan 28, 2024
Primary completion
Nov 15, 2024
Completion
Dec 17, 2024
Last update
Dec 24, 2024

Study contacts

Faiza Sharif, PHD
principal investigator · Associate Professor
Hira Riaz, MSOMPT
study director · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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