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StrokeCEMRA-PNFNCT06539247

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

A study testing Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS) and Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS) in people with Stroke and Pain, run by University of Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Stroke, Pain, Gait, Drop Foot
What is being tested?
Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS) and Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 sitePakistan
Study dates
28 Jan 2024to 17 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 9Show fewer
  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Pakistan1 site

  • University of Lahore

    Lahore, Punjab Province, 54590

Other trials in Pakistan

About this study

Official title: 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.

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.

Being tested
Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS), Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)
Keywords
Motor Relearning, Proprioceptive Neuromuscular Facilitation, Muscle Stimulation, Gait Analysis, Functional Mobility
Medical subject headings
Stroke, Pain, Gait Disorders, Neurologic, Peroneal Neuropathies, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06539247
Study groupRoleWhat they receive
Motor Relearning Approach with EMS (MRA + EMS)ExperimentalThis 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)
Receives: Combination Product: Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS)
Proprioceptive Neuromuscular Facilitation with EMS (PNF + EMS)ExperimentalThis 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)
Receives: Combination Product: Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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).

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

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start28 Jan 2024
  3. Primary completion15 Nov 2024
  4. Study completion17 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: Motor Relearning Approach with EMS Group B: Proprioceptive Neuromuscular Facilitation Technique with EMS
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06539247
Sponsor's protocol ID
Rec-UOL-/200/08/24
Acronym
CEMRA-PNF
Status last verified
Dec 2024
First submitted
1 Aug 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Motor Relearning Program with Electrical Muscle Stimulation (MRA + EMS) and Proprioceptive Neuromuscular Facilitation Technique with Electrical Muscle Stimulation (PNF + EMS) in people with Stroke and Pain, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait analysis (time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06539247, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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