- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07598435
Rhythmic Initiation vs Isometric Training for Arm Recovery After Stroke (RIITSTROKE)
1. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Dr Muhammad Ateeb, PhD Public Health
- Telefonnummer: +923357333383
- E-post: mateeb.oric@tuf.edu.pk
Studer Kontakt Backup
- Navn: Dr Marium Zafar, MS-NMPT
- Telefonnummer: +92 300 4561972
- E-post: mariumzafar.dpt@tuf.edu.pk
Studiesteder
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistan, 3800
- Rekruttering
- The University of Faisalabad
-
Ta kontakt med:
- Dr Anbreena Rasool, Doctor of Physical Therapy
- Telefonnummer: +92 345 7936825
- E-post: anbreenarasool.DPT@tuf.edu.pk
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Upper Extremity Motor Function
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Upper Limb Muscle Strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
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Studer hoveddatoer
Studiestart (Faktiske)
19. januar 2026
Primær fullføring (Faktiske)
19. mai 2026
Studiet fullført (Antatt)
24. juni 2026
Datoer for studieregistrering
Først innsendt
13. mai 2026
Først innsendt som oppfylte QC-kriteriene
13. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TUF/EIRB/ 218 /26
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