- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07937111
COMPARATIVE ANALYSIS OF DUAL-TASK COGNITIVE-MOTOR TRAINING AND ACTION OBSERVATION THERAPY ON UPPER LIMB FUNCTIONAL RECOVERY AND HAND DEXTERITY IN PATIENTS WITH SUBACUTE STROKE
This randomized controlled trial aims to compare the effects of dual-task cognitive-motor training and action observation therapy on upper limb functional recovery and hand dexterity in patients with subacute stroke.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Awais Rafiq Awais Rafiq, DPT, MS-PT NPT
- Telefonnummer: +923355365648
- E-post: awaissrafiq0900@gmail.com
Studera Kontakt Backup
- Namn: Nazish Rafique Dr Nazish Rafique, DPT, MS-PT NMPT
- Telefonnummer: 03002132436
- E-post: nazish.rafique@uipt.iiui.edu.pk
Studieorter
-
-
Punjab Province
-
Islamabad, Punjab Province, Pakistan
- Rekrytering
- Orthofit Physiotherapy
-
Kontakt:
- Nazish Rafique
- Telefonnummer: 03002132436
- E-post: nazish.rafique@uipt.iiui.edu.pk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- First-ever ischemic or hemorrhagic stroke (confirmed by CT/MRI).
- Subacute stage of stroke 3-6 months
- Age 40-75 years, male andfemale..
- Mini Mental State Examination (MMSE) >24.
- Manual muscle testing (MMT) > 3.
Exclusion Criteria:
- Bilateral stroke or brainstem stroke.
- Severe neglect, apraxia, or global aphasia.
- Severe visual field defects such as hemianopia.
- Uncontrolled hypertension, unstable cardiac issues, and uncontrolled diabetes.
- Neurological disorders (Parkinson's, MS, and Alzheimer's).
- Fractures or contracture (Modified Ashworth Scale < 2).
- Pre-existing musculoskeletal Issues in the upper limb
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group A (Dual-Task Cognitive-Motor Training)
Dual-Task Cognitive-Motor Training |
Week 1: Simple Cognitive + Motor Tasks Motor Tasks
Motor Tasks ADL-based:
Motor Tasks Complex upper limb activities:
|
|
Aktiv komparator: Group B (Action Observation Therapy)
Action Observation Therapy |
Week 1: Basic Gross Motor Tasks Observation Tasks Patient watches videos or therapist demonstrations of:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Barthel Index (BI)
Tidsram: Baseline, 2nd week, 4th week
|
It measures independence in daily activities. Test-retest reliability: ICC = 0.89 (High stability) |
Baseline, 2nd week, 4th week
|
|
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Tidsram: Baseline, 2nd week, 4th week
|
It is a stroke-specific, performance-based outcome measure used to assess upper limb motor recovery following a stroke. The FMA-UE consists of 33 items evaluating reflex activity, voluntary movement within and out of synergy, wrist and hand function, and coordination/speed. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 indicating optimal motor function. |
Baseline, 2nd week, 4th week
|
|
Box and Block Test (BBT)
Tidsram: Baseline, 2nd week, 4th week
|
It measures gross manual dexterity / hand function. Concurrent validity: r = 0.801 (Strong correlation) |
Baseline, 2nd week, 4th week
|
|
Trail Making Test Part B
Tidsram: Baseline, 2nd week, 4th week
|
It measures attention shifting, processing speed, and executive function. ICC = 0.93 Excellent test-retest reliability |
Baseline, 2nd week, 4th week
|
Samarbetspartners och utredare
Utredare
- Studiestol: Nazish Rafique, Ibadat International University
Publikationer och användbara länkar
Allmänna publikationer
- 1. Alvarez-Rodríguez M., López-Dolado, E., Salas-Monedero, M., Lozano-Berrio, V., Ceruelo-Abajo, S., Gil-Agudo, A., & de los Reyes-Guzmán, A. (2020). Concurrent validity of a virtual version of Box and Block Test for patients with neurological disorders. World Journal of Neuroscience, 10(1), 79-89. 2. An H. S., & Kim, D. J. (2021). Effects of activities of daily living-based dual-task training on upper extremity function, cognitive function, and quality of life in stroke patients. Osong Public Health and Research Perspectives, 12(5), 304-313. 3.Borges, L. R. D. M., Fernandes, A. B. G. S., Oliveira dos Passos, J., Rego, I. A. O., & Campos, T. F. (2022). Action observation for upper limb rehabilitation after stroke. Cochrane Database of Systematic Reviews, 2022(8), CD011887. 4. GB 2021 Stroke Risk Factor Collaborators. (2024). Global, regional, and national burden of stroke and its risk factors, 1990-2021: A systematic analysis for the Global Burden of Disease Study 2021. The Lancet Neurology, 23(10), 973-1003. 5.Han, C., Wang, Q., Meng, P. P., & Qi, M. Z. (2013). Effects of intensity of arm training on hemiplegic upper extremity motor recovery in stroke patients: A randomized controlled trial. Clinical Rehabilitation, 27(1), 75-81. 6.Khalid, Z., Gulalai, Qamar, K., Khan, M., Afridi, A., & Rahat, A. (2024). Effects of action observation exercises with complex tasks on upper limb function in acute stroke. Journal of Health and Rehabilitation Research, 4(1), 318-324. 7.Mancuso, M., Di Tondo, S., Costantini, E., Damora, A., Sale, P., & Abbruzzese, L. (2021). Action Observation Therapy for upper limb recovery in patients with stroke: A randomized controlled pilot study. Brain Sciences, 11(3), 290. 8.Milani, G., Baroni, A., Galluccio, M., Fadiga, L., & Rossettini, G. (2025). Action Observation Training for upper limb stroke rehabilitation: A pilot study on the role of attention. Journal of Clinical Medicine, 14(18), 6618. Page, S. J., Hade, E., & Persch, A. (2015). Psycho
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIUI/RERC/ADT/2026/07/380
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .