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

NCT06539247 | Completed

• 1 other identifier: Rec-UOL-/200/08/24
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Pain; Gait, Drop Foot; Foot Drop; Hemiplegia

Keywords

Motor Relearning; Proprioceptive Neuromuscular Facilitation; Muscle Stimulation; Gait Analysis; Functional Mobility

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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).

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

Secondary Outcomes (2)

• Functional Ability

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

• Pain intensity

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

Study Arms (2)

Motor Relearning Approach with EMS (MRA + EMS)

EXPERIMENTAL

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)

Proprioceptive Neuromuscular Facilitation with EMS (PNF + EMS)

EXPERIMENTAL

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

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.

Motor Relearning Approach with EMS (MRA + EMS)

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.

Proprioceptive Neuromuscular Facilitation with EMS (PNF + EMS)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 33482005 BACKGROUND

• 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.

  PMID: 22078779 BACKGROUND

• 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.

  PMID: 20531158 BACKGROUND

• 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.

  PMID: 17332444 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Pain; Gait Disorders, Neurologic; Peroneal Neuropathies; Hemiplegia

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Paralysis

Study Officials

• Faiza Sharif, PHD

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Hira Riaz, MSOMPT

  Assistant Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded assessor was considered to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: Group A: Motor Relearning Approach with EMS Group B: Proprioceptive Neuromuscular Facilitation Technique with EMS

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: January 28, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 17, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)