Rhythmic Initiation vs Isometric Training for Arm Recovery After Stroke (RIITSTROKE)

University of Faisalabad

Status: Enrolling

Conditions: Upper Extremity Paresis; Stroke

Treatments: Other: Rhythmic Initiation (PNF technique); Other: Isometric Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07598435

TUF/EIRB/ 218 /26

Details and patient eligibility

About

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.

Full description

This is a single-blind, parallel-arm, randomized clinical trial. Eligible participants will be recruited from Medina Teaching Hospital and The Canal Hospital in Faisalabad, Pakistan. Inclusion criteria include age 40-60 years, both genders, clinically diagnosed first-ever subacute stroke (1-6 months post-onset), and unilateral upper limb involvement. Exclusion criteria include severe spasticity (Modified Ashworth Scale >3), recurrent or bilateral stroke, shoulder subluxation or pain limiting movement, and cognitive or perceptual deficits. After providing written informed consent, participants will be randomly assigned in a 1:1 ratio to either Group A (Rhythmic Initiation) or Group B (Isometric Resistance Training). The randomization sequence will be generated using computer software, and allocation will be concealed in sealed opaque envelopes. The outcome assessor will be blinded to group assignment. Group A intervention: Rhythmic Initiation follows a four-step sequence-passive movement, active-assistive movement, active movement, and light resisted movement-using PNF diagonal patterns (D1 flexion/extension) for the affected upper limb. Each session lasts 30 minutes, 5 days per week for 4 weeks. The therapist emphasizes smooth rhythm and provides verbal cues throughout. Group B intervention: Isometric Resistance Training involves static contractions of major upper limb muscles including shoulder abductors, elbow flexors/extensors, and wrist flexors/extensors. Each contraction is held for 6 to 10 seconds at approximately 60-70% of maximum voluntary contraction. Participants perform 10 repetitions per muscle group, completing 3 sets. Rest periods of 30 to 60 seconds are provided between sets. Sessions last 30 minutes, 5 days per week for 4 weeks. Outcome measures are assessed at baseline (week 0) and after 4 weeks of intervention. The primary outcome is upper extremity motor function measured by the Fugl-Meyer Assessment Upper Extremity (FMA-UE) scale. Secondary outcomes include muscle strength measured by handheld dynamometry (shoulder, elbow, wrist), coordination measured by the timed finger-to-nose test, and spasticity measured by the Modified Ashworth Scale (MAS). Data will be analyzed using SPSS version 25. Paired t-tests will examine within-group changes from baseline to week 4. Independent t-tests will compare between-group differences. A p-value less than 0.05 will be considered statistically significant.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Rhythmic Initiation Group

Experimental group

Description:

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.

Treatment:

Other: Rhythmic Initiation (PNF technique)

Isometric Resistance Training Group

Experimental group

Description:

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.

Treatment:

Other: Isometric Resistance Training