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

June 1, 2026 updated by: Dr. Marium Zafar, University of Faisalabad

Comparative Effects of Rhythmic Initiation and Isometric Resistance Training on Upper Limb Motor Function, Strength, and Coordination in Subacute Stroke Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • Recruiting
        • The University of Faisalabad
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rhythmic Initiation Group
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)
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.
Experimental: Isometric Resistance Training Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Upper Extremity Motor Function
Time Frame: Baseline (week 0) and post-intervention (week 4)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Upper Limb Muscle Strength
Time Frame: Baseline (week 0) and post-intervention (week 4)
Measured using a handheld dynamometer. Maximum isometric strength recorded for shoulder abductors, elbow flexors, elbow extensors, wrist flexors, and wrist extensors. Three trials per muscle group; best score recorded in kilograms or Newtons.
Baseline (week 0) and post-intervention (week 4)
Change in Upper Limb Coordination
Time Frame: Baseline (week 0) and post-intervention (week 4)
Measured by the timed finger-to-nose test. Patient seated, asked to alternately touch examiner's finger (held at shoulder height with arm fully extended) and then their own nose as quickly as possible. Time to complete 10 repetitions recorded in seconds.
Baseline (week 0) and post-intervention (week 4)
Change in Spasticity
Time Frame: Baseline (week 0) and post-intervention (week 4)
Measured by the Modified Ashworth Scale (MAS). Spasticity graded from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension). Assessed at shoulder, elbow, and wrist.
Baseline (week 0) and post-intervention (week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TUF/EIRB/ 218 /26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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