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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07598435
Rhythmic Initiation vs Isometric Training for Arm Recovery After Stroke (RIITSTROKE)
1 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dr Muhammad Ateeb, PhD Public Health
- Numero di telefono: +923357333383
- Email: mateeb.oric@tuf.edu.pk
Backup dei contatti dello studio
- Nome: Dr Marium Zafar, MS-NMPT
- Numero di telefono: +92 300 4561972
- Email: mariumzafar.dpt@tuf.edu.pk
Luoghi di studio
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- Reclutamento
- The University of Faisalabad
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Contatto:
- Dr Anbreena Rasool, Doctor of Physical Therapy
- Numero di telefono: +92 345 7936825
- Email: anbreenarasool.DPT@tuf.edu.pk
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Sperimentale: 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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Upper Extremity Motor Function
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Upper Limb Muscle Strength
Lasso di tempo: 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)
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Change in Upper Limb Coordination
Lasso di tempo: Baseline (week 0) and post-intervention (week 4)
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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.
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Baseline (week 0) and post-intervention (week 4)
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Change in Spasticity
Lasso di tempo: Baseline (week 0) and post-intervention (week 4)
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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.
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Baseline (week 0) and post-intervention (week 4)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
19 gennaio 2026
Completamento primario (Effettivo)
19 maggio 2026
Completamento dello studio (Stimato)
24 giugno 2026
Date di iscrizione allo studio
Primo inviato
13 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 maggio 2026
Primo Inserito (Effettivo)
20 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TUF/EIRB/ 218 /26
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