- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07616622
Roods vs PNF for Upper Limb Function in Acute MCA Stroke (RVP-MCA)
23. mai 2026 oppdatert av: Dr. Marium Zafar, University of Faisalabad
Comparison Between Roods Facilitatory Techniques and Sequential PNF Pattern on Upper Limb Function in Acute Phase of Middle Cerebral Artery Stroke Patients
Middle cerebral artery (MCA) stroke often causes weakness or stiffness in the arm and hand, making daily activities difficult.
This study compares two physical therapy approaches - Rood's facilitatory techniques (using touch, quick stretch, and ice to activate muscles) and PNF sequential patterns (using diagonal movement patterns) - to improve arm function in acute stroke patients.
Both groups will also receive neuromuscular electrical stimulation (NMES).
A total of 28 patients will be randomly assigned to one of two groups and receive treatment three times per week for eight weeks.
Arm function will be measured using the Fugl-Meyer Assessment, and muscle stiffness will be measured using the Modified Ashworth Scale before and after treatment.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Detaljert beskrivelse
This is a single-blind, parallel-group randomized controlled trial.
The study will be conducted at three settings in Faisalabad, Pakistan: Allied Hospital, Madinah Teaching Hospital, and Shahid Heera's Health Clinic.
Adult patients (≥18 years) with CT or MRI-confirmed MCA stroke (ischemic or hemorrhagic), mild to moderate upper limb motor dysfunction (MRC ≥2), and cognitive competence (MoCA ≥19) will be included.
Exclusion criteria include severe comorbidities, fixed contractures, severe cognitive impairment, skin contraindications to sensory stimulation, and inability to provide consent.
A sample size of 28 participants (14 per group) was calculated using Rao soft app based on previous literature.
Participants will be randomly assigned using a computer-generated sequence.
The single-blind design keeps participants unaware of group allocation.
Group A receives NMES followed by Rood's facilitatory techniques: quick stretch before or during movement to activate muscle spindles, tactile stimulation (light stroking) over the muscle belly for 10-20 seconds, and icing for 5-7 seconds on the tendon or muscle surface immediately preceding activation.
Group B receives NMES followed by PNF sequential training using conventional upper limb diagonal functional patterns (D1 and D2).
PNF techniques include rhythmic initiation, dynamic reversals, repetitive contractions, and combination of isotonic contractions with moderate resistance, performing 8-12 repetitions per pattern over 20-30 minutes per session.
NMES parameters: biphasic waveform at 30-40Hz frequency with pulse duration of 200-300μs, producing comfortable visible contraction, administered for 30 minutes per session.
Both groups receive interventions three times per week for eight weeks.
Outcome measures: Fugl-Meyer Assessment for Upper Extremity (FMA-UE, score range 0-66) measures motor function; Modified Ashworth Scale (MAS, score range 0-4) measures muscle tone.
Assessments are conducted at baseline and post-intervention by a qualified physiotherapist.
Data will be analyzed using SPSS version 22.
Studietype
Intervensjonell
Registrering (Antatt)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
-
-
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:
- Adults (40-60 years) with confirmed MCA stroke (ischemic or hemorrhagic) on neuroimaging (CT or MRI)
- Mild to moderate upper limb motor dysfunction with MRC ≥2 for proximal limb motor strength
- Cognitive competence to understand instructions (MoCA ≥19 or equivalent)
- First stroke, acute or subacute phase
- Willingness to provide written informed consent
- Both male and female genders
Exclusion Criteria:
- Severe coexisting medical disorders (heart, liver, kidney failure; malignant tumors)
- Fixed musculoskeletal abnormalities or contracture in affected upper limb
- Severe cognitive impairment or aphasia preventing adherence or consent (MMSE below threshold)
- Skin sores, ulcers, or hypersensitivity (e.g., to cold) contraindicated for sensory stimulation
- Refusal or inability to give informed consent
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: Rood's Facilitatory Techniques Group
Participants receive neuromuscular electrical stimulation (NMES) followed by Rood's facilitatory techniques including quick stretch, tactile stimulation for 10-20 seconds over muscle belly, and icing for 5-7 seconds on tendon or muscle surface.
Interventions delivered three times per week for eight weeks.
|
Biphasic waveform NMES at 30-40Hz frequency with pulse duration of 200-300μs, producing comfortable but visible muscle contraction.
Applied to affected upper limb for 30 minutes per session, three times per week for eight weeks.
Quick stretch applied before or during movement to activate muscle spindles; tactile stimulation (light stroking) over muscle belly for 10-20 seconds; icing for 5-7 seconds on tendon or muscle surface immediately preceding activation.
Applied three times per week for eight weeks following NMES.
|
|
Aktiv komparator: PNF Sequential Pattern Group
Participants receive neuromuscular electrical stimulation (NMES) followed by PNF sequential training with upper limb diagonal functional patterns (D1 and D2), including rhythmic initiation, dynamic reversals, repetitive contractions, and isotonic contractions with moderate resistance (8-12 repetitions per pattern over 20-30 minutes).
Interventions delivered three times per week for eight weeks.
|
Biphasic waveform NMES at 30-40Hz frequency with pulse duration of 200-300μs, producing comfortable but visible muscle contraction.
Applied to affected upper limb for 30 minutes per session, three times per week for eight weeks.
PNF sequential training with upper limb diagonal functional patterns (D1 and D2).
Techniques include rhythmic initiation, dynamic reversals, repetitive contractions, and combination of isotonic contractions with moderate resistance according to patient's capabilities.
Each session includes 8-12 repetitions per pattern over 20-30 minutes, three times per week for eight weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Upper Limb Motor Function
Tidsramme: Baseline and 8 weeks (post-intervention)
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE).
A standardized 66-point scale assessing motor recovery after stroke based on Brunnstrom stages.
Evaluates shoulder, elbow, wrist, hand, and coordination functions.
Higher scores indicate better motor function.
|
Baseline and 8 weeks (post-intervention)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle Tone
Tidsramme: Baseline and 8 weeks (post-intervention)
|
Modified Ashworth Scale (MAS).
A 5-point scale (0-4) measuring resistance during passive stretching of the affected upper limb muscles.
0 = normal tone; 4 = rigidity.
Assesses spasticity reduction.
|
Baseline and 8 weeks (post-intervention)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2026
Primær fullføring (Antatt)
15. juni 2026
Studiet fullført (Antatt)
15. juli 2026
Datoer for studieregistrering
Først innsendt
23. mai 2026
Først innsendt som oppfylte QC-kriteriene
23. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Hjerneinfarkt
- Hjerneiskemi
- Infarkt
- Nekrose
- Iskemi
- Intrakranielle arterielle sykdommer
- Cerebrale arterielle sykdommer
- Cerebralt infarkt
- Patologiske tilstander, tegn og symptomer
- Slag
- Infarkt, midtre cerebral arterie
- Motorisk aktivitet
- Bevegelse
- Muskel- og skjelettfysiologiske fenomener
- Muskel- og skjelett og nevrale fysiologiske fenomener
- Terapeutikk
- Fysioterapi -modaliteter
- Pasientbehandling
- Treningsterapi
- Rehabilitering
- Ettervern
- Kontinuitet i pasientbehandling
- Øvelse
- Muskelstrekkøvelser
Andre studie-ID-numre
- TUF/EIRB/ 220 /26
Plan for individuelle deltakerdata (IPD)
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