NCT07598435

Brief Summary

Stroke is a leading cause of long-term disability worldwide. Many stroke survivors experience persistent weakness, loss of motor control, and poor coordination in their upper limb, which limits their ability to perform daily activities and return to independent living. This study compares two physical therapy approaches for patients in the subacute stage of stroke recovery (1 to 6 months after stroke). The first approach is Rhythmic Initiation, a technique from Proprioceptive Neuromuscular Facilitation (PNF) that uses smooth, guided movement patterns progressing from passive to active movement. The second approach is Isometric Resistance Training, which involves holding static muscle contractions against resistance without moving the joint. The study will enroll 40 patients aged 40 to 60 years with unilateral upper limb weakness from a first-time stroke. Participants will be randomly assigned to receive either Rhythmic Initiation or Isometric Resistance Training for 30 minutes per session, 5 days per week, for 4 weeks. The researchers will measure changes in motor function, muscle strength, coordination, and spasticity before and after the 4-week intervention. The results will help physiotherapists understand which approach is more effective for upper limb rehabilitation in subacute stroke patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jan 2026Jun 2026

Study Start

First participant enrolled

January 19, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2026

Expected
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Stroke Rehabilitation, PNF, Isometric Exercise, Upper Limb, Motor Function, Subacute Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Upper Extremity Motor Function

    Measured by the Fugl-Meyer Assessment Upper Extremity (FMA-UE) scale. The FMA-UE evaluates motor function, sensation, coordination, and reflex activity in the upper limb. Scores range from 0 to 66, with higher scores indicating better motor function. The assessment is performed by a blinded outcome assessor.

    Baseline (week 0) and post-intervention (week 4)

Secondary Outcomes (3)

  • Change in Upper Limb Muscle Strength

    Baseline (week 0) and post-intervention (week 4)

  • Change in Upper Limb Coordination

    Baseline (week 0) and post-intervention (week 4)

  • Change in Spasticity

    Baseline (week 0) and post-intervention (week 4)

Study Arms (2)

Rhythmic Initiation Group

EXPERIMENTAL

Participants receive Rhythmic Initiation technique for the affected upper limb. Each 30-minute session follows a sequence: passive movement, active-assistive movement, active movement, and light resisted movement using PNF diagonal patterns (D1 or D2). Sessions occur 5 days per week for 4 weeks.

Other: Rhythmic Initiation (PNF technique)

Isometric Resistance Training Group

EXPERIMENTAL

Participants receive isometric strengthening exercises for upper limb muscles (shoulder abductors, elbow flexors/extensors, wrist flexors/extensors). Contractions held 6-10 seconds at 60-70% MVC, 10 repetitions × 3 sets. Sessions occur 30 minutes, 5 days/week for 4 weeks.

Other: Isometric Resistance Training

Interventions

What: Rhythmic Initiation technique from PNF. How: Therapist guides patient's affected upper limb through a four-step sequence-passive movement (therapist moves limb), active-assistive movement (patient helps with therapist assistance), active movement (patient moves independently), and light resisted movement (therapist adds gentle resistance). The movement follows PNF diagonal pattern D1 (flexion-adduction-external rotation to extension-abduction-internal rotation) or D2. Verbal cues emphasize smooth, rhythmic motion. When: 30 minutes per session, 5 days per week. How long: 4 weeks total. By whom: Trained physical therapist. Where: Outpatient rehabilitation department.

Rhythmic Initiation Group

What: Isometric Resistance Training (static muscle contractions without joint movement). How: Patient contracts target muscle against resistance provided by therapist or stationary object. Target muscles include shoulder abductors, elbow flexors, elbow extensors, wrist flexors, and wrist extensors. Each contraction held 6-10 seconds at 60-70% of maximum voluntary contraction. Patient performs 10 repetitions per muscle group, completing 3 sets. Rest 30-60 seconds between sets. When: 30 minutes per session, 5 days per week. How long: 4 weeks total. By whom: Trained physical therapist. Where: Outpatient rehabilitation department.

Isometric Resistance Training Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically diagnosed subacute stroke (1 to 6 months post-onset)
  • Unilateral upper limb involvement
  • Age 40 to 60 years
  • Both genders
  • Medically stable and able to participate in physical therapy
  • Able to provide informed consent

You may not qualify if:

  • Severe spasticity (Modified Ashworth Scale score \>3)
  • Recurrent or bilateral stroke
  • Shoulder subluxation
  • Shoulder or upper limb pain limiting active movement
  • Cognitive or perceptual deficits impairing ability to follow instructions
  • Other neurological disorder affecting upper limb (e.g., Parkinson's disease, multiple sclerosis)
  • Orthopedic condition affecting upper limb function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

RECRUITING

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Marium Zafar, MS-NMPT

CONTACT

Dr Muhammad Ateeb, PhD Public Health

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 20, 2026

Study Start

January 19, 2026

Primary Completion

May 19, 2026

Study Completion (Estimated)

June 24, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations