StrokeRIITSTROKENCT07598435
Rhythmic Initiation vs Isometric Training for Arm Recovery After Stroke
A study testing Rhythmic Initiation (PNF technique) and Isometric Resistance Training in people with Stroke and Upper Extremity Paresis, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- Rhythmic Initiation (PNF technique) and Isometric Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Jan 2026to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
The University of Faisalabad
Faisalābad, Punjab Province, 3800
Dr Anbreena Rasool, Doctor of Physical Therapy, +92 345 7936825, anbreenarasool.DPT@tuf.edu.pk
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- Rhythmic Initiation (PNF technique), Isometric Resistance Training
- Keywords
- Stroke Rehabilitation, PNF, Isometric Exercise, Upper Limb, Motor Function
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Initiation (PNF technique)Other
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.
Isometric Resistance TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Isometric Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) and post-intervention (week 4)
Secondary outcomes (3)
Change in Upper Limb Muscle Strength
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.
Measured: Baseline (week 0) and post-intervention (week 4)
Change in Upper Limb Coordination
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.
Measured: Baseline (week 0) and post-intervention (week 4)
Change in Spasticity
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.
Measured: Baseline (week 0) and post-intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start19 Jan 2026
- Primary completion19 May 2026
- Study completion24 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marium Zafar, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598435
- Sponsor's protocol ID
- TUF/EIRB/ 218 /26
- Acronym
- RIITSTROKE
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Rhythmic Initiation and Isometric Resistance Training on Upper Limb Motor Function, Strength, and Coordination in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT07598435
- Acronym / sponsor ID
- RIITSTROKE / TUF/EIRB/ 218 /26
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- Stroke Rehabilitation, PNF, Isometric Exercise, Upper Limb, Motor Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 24 Jun 2026 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Initiation Group | Experimental | Other: Rhythmic Initiation (PNF technique)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. |
| Isometric Resistance Training Group | Experimental | Other: Isometric Resistance TrainingParticipants 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Rhythmic Initiation Group |
| Isometric Resistance TrainingWhat: 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. | Other | Isometric Resistance Training Group |
Primary outcome
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.
3 secondary outcomes
Change in Upper Limb Muscle Strength
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in Upper Limb Coordination
Time frame: Baseline (week 0) and post-intervention (week 4)
Change in Spasticity
Time frame: Baseline (week 0) and post-intervention (week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Initiation (PNF technique) and Isometric Resistance Training in people with Stroke and Upper Extremity Paresis, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Marium Zafar, MS-NMPT (+92 300 4561972, mariumzafar.dpt@tuf.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Motor Function (time frame: Baseline (week 0) and post-intervention (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.