- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07616622
Roods vs PNF for Upper Limb Function in Acute MCA Stroke (RVP-MCA)
23 maj 2026 uppdaterad 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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
28
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Upper Limb Motor Function
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Muscle Tone
Tidsram: 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)
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2026
Primärt slutförande (Beräknad)
15 juni 2026
Avslutad studie (Beräknad)
15 juli 2026
Studieregistreringsdatum
Först inskickad
23 maj 2026
Först inskickad som uppfyllde QC-kriterierna
23 maj 2026
Första postat (Faktisk)
1 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Patologiska processer
- Hjärninfarkt
- Hjärnischemi
- Infarkt
- Nekros
- Ischemi
- Intrakraniella arteriella sjukdomar
- Cerebrala arteriella sjukdomar
- Cerebral infarkt
- Patologiska tillstånd, tecken och symtom
- Stroke
- Infarkt, mellersta cerebral artären
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Terapeutik
- Fysioterapimetoder
- Patientvård
- Träningsterapi
- Rehabilitering
- Eftervård
- Kontinuitet i patientvård
- Utöva
- Muskelsträckningsövningar
Andra studie-ID-nummer
- TUF/EIRB/ 220 /26
Plan för individuella deltagardata (IPD)
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