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Completed

NCT Number: NCT07331714

Comparative Effects of PNF and mCIMT on Lower Limb Function in Patient With Stroke

Stroke, which is frequently characterized by weakness, poor balance, and decreased mobility that impede independence in everyday activities, has been identified as a major cause of long-term impairment globally. There have been reports of an increasing number of stroke survivors in Pakistan, however access to proper rehabilitation is sometimes hampered by a lack of resources and awareness. It is thought that improving walking ability, balance, and day-to-day functioning requires the restoration of lower limb function. Modified Constraint-Induced Movement Therapy (mCIMT) and Proprioceptive Neuromuscular Facilitation (PNF) have been found to be successful physiotherapy interventions for improving motor recovery, but there is little comparative data on their impact on lower limb function.

The purpose of this study is to examine the effects of PNF and mCIMT in order to identify whether strategy is better for lower limb rehabilitation after stroke. The findings are expected to give physiotherapists evidence-based recommendations for treatment choices, enabling stroke patients to recover more quickly and become more independent. In the end, community-level advantages are anticipated in the form of less impairment, less caregiver stress, and an overall improvement in the quality of life for stroke victims.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sehat Medical Complex Hanjerwal

Lahore, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are chronic stroke post-stroke or longer will be included. Both males and females are included. Stroke between ages 45 -75 years. Mild to moderate disability assessed using the Modified Rankin Scale (mRS) with a score of 2 to 3.

Pain more than 4 on visual analogue scale in the affected lower limb.

Exclusion criteria

Recurring stroke Cognitive impairment (Less than 24 points on Mini Mental Status Examination) Peripheral vascular disease (such as Parkinsonism, epilepsy, multiple sclerosis, or spinal cord injury.

No surgical procedure performed on lower limbs

Treatment and study plan

PNF

Other

PNF training was administered for 10 weeks (Time), 5 days per week (Frequency), for 45 minutes per session (Time), using moderate-to-maximal manual resistance (Intensity) with rhythmic initiation, diagonal patterns, dynamic reversals, and resistance training (Type)

mCIMT

Other

mCIMT was administered for 10 weeks (Duration), 5 days per week (Frequency), for 45 minutes per session (Time), involving task-oriented lower limb activities including side stepping, ball kicking, stair climbing, and knee control on a step (Type), performed at moderate functional intensity (Intensity).

Primary outcomes

  1. motor function

    Time frame: 10 week

    The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is a widely used and recommended scale for evaluation of post-stroke motor impairment. The FMA-LE is a reliable tool for assessment of motor impairment both within and between raters early after stroke. The scale can be recommended internationally. A unified international use of FMA-LE would allow comparison of stroke recovery outcomes worldwide and thereby potentially improve the quality of stroke rehabilitation. The scale is recognized as a gold standard and is recommended both for clinical use and research world wide. The scale includes assessment of reflex activity, voluntary movements within and outside of synergies, ability to perform isolated movement, and coordination. This means that the scale is valid for determining level of motor function in people with stroke.The total score of the Fugl-Meyer Assessment for the Lower Extremity (FMA-LE) is 34 points.Each item is scored on a 0-2 scale.

  2. Muscle Strength

    Time frame: 10 week

    The Motricity Index (MI) is an ordinal measure used to assess muscle strength in individuals with post-stroke hemiparesis, originally developed by Demeurisse et al. in 1980. It evaluates three key upper limb movements-pinch grip (PG), elbow flexion (EF), and shoulder abduction (SA)-and three lower limb movements-ankle dorsiflexion (AD), knee extension (KE), and hip flexion (HF), each graded using the Medical Research Council (MRC) 6-point scale and then converted into modified weighted scores. A total score ranging from 0 (complete paresis) to 100 (normal strength) is computed for each limb, and a side score may also be obtained by averaging upper and lower limb totals. Administration time ranges from 5 to 20 minutes depending on the examiner's experience and the severity of impairment. The MI demonstrates excellent inter-rater reliability, strong construct and concurrent validity with established motor impairment scales, and good predictive validity as initial MI scores correlates

  3. range of motion

    Time frame: 10 week

    Goniometer refers to the measurement of angles in particular the measurement of angles created at human joints by the bones of the body. These measurement are obtained by placing the parts of measuring instrument, called a goniometer. Goniometery may be used to determine both a particular joint position and the total amount of motion available at a joint. The data analysis revealed the inter tester reliability and validity were high

  4. stroke specific quality of life

    Time frame: 10 week

    Stroke-specific quality of life (SS-QOL) is a standardized, reliable, and disease-specific questionnaire designed to evaluate quality of life in individuals with stroke. It consists of twelve domains and forty-nine items, each scored on a 5-point Likert scale. The domains include energy, language, mobility, self-care, family roles, social roles, vision, mood, thinking, upper extremity function, and work and productivity. The SS-QOL has been widely validated and is considered an effective tool for assessing functional and psychosocial outcomes in stroke patients.Stroke-Specific Quality of Life (SS-QOL) scale consists of 49 items across 12 domains.Each item is scored on a 5-point Likert scale (1-5). Minimum possible total score is 49 and maximum possible total score is 245.Higher scores indicate better quality of life in stroke patients.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Proprioceptive Neuromuscular Facilitation and Modified Constraint Induced Movement Therapy on Lower Limb Function in Patient With Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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