Clinical trial NCT06539247: MRP Verses PNF on Pain, Foot Drop, Gait and Functional Mobility in Hemiplegic Patients.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Pain
Gait, Drop Foot
Foot Drop
Hemiplegia
Keywords: Motor Relearning
Proprioceptive Neuromuscular Facilitation
Muscle Stimulation
Gait Analysis
Functional Mobility
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Motor Relearning Approach with EMS Group B: Proprioceptive Neuromuscular Facilitation Technique with EMS
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait analysis
timeFrame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
measure: Foot Drop
timeFrame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
Secondary outcomes:
measure: Functional Ability
timeFrame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
measure: Pain intensity
timeFrame: 8 weeks (baseline, fourth week and then at the end of the 8 week)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore
state: Punjab
Study officials:
affiliation: Associate Professor
name: Faiza Sharif, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Hira Riaz, MSOMPT
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.