- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07734818
Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Haziqa Pari, MSNMPT
- Telefonnummer: +923044516865
- E-post: haziqamalik44@gmail.com
Studer Kontakt Backup
- Navn: Aruba Saeed, Supervisor
- Telefonnummer: +92 334 4399403
- E-post: aruba.saeed@ubas.edu.pk
Studiesteder
-
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Lahore University of Biological and Applied Sciences
-
Ta kontakt med:
- Aruba Saeed, PhD
- Telefonnummer: 0334 4399403
- E-post: arubasaeedpt@gmail.com
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Lahore, Punjab Province, Pakistan, 54000
- Services Hospital
-
Ta kontakt med:
- Aruba Saeed, Phd
- Telefonnummer: 0334 4399403
- E-post: arubaseed@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Subacute and chronic stroke patient > 3 months post stroke. Modified Ashworth scale <3 MOCA > 24. An ability to understand the command First ever stroke Grade II, III, IV on Functional mobility Scale Able to use and comprehend smart phone.
Exclusion Criteria:
Posterior circulation stroke. Vestibular disorders, paroxysmal vertigo Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome Presence of orthopedic diseases involving the upper limb
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Clinical Exercise group
Participants in the Clinical Exercise-Based Group will receive standard physiotherapy in a clinical setting, including range-of-motion, strengthening, task-specific functional, and repetitive motor exercises for the affected upper limb.
Sessions will be conducted 3 times per week for 45 minutes over 8 weeks following standardized clinical protocols.
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Range-of-Motion Exercises: Include passive, active-assisted, and active movements of the shoulder, elbow, wrist, and fingers along with stretching to maintain joint mobility and reduce stiffness. Strengthening Exercises: Involve resisted upper limb exercises using TheraBands, weights, and therapy tools to improve shoulder, elbow, forearm, wrist, and hand strength, including grip and pinch strengthening. Task-Specific Functional Activities: Focus on functional and daily-life tasks such as reaching, grasping, object manipulation, pegboard tasks, ADL simulations, fine motor activities, and repetitive bilateral upper-limb training to enhance coordination and motor recovery. |
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Eksperimentell: m Health
Participants receive upper limb rehabilitation via a mobile app with structured exercises for range of motion, strengthening, and functional tasks targeting the shoulder, elbow, wrist, and hand to improve motor control and coordination.
Sessions last 45 minutes, 3 times weekly for 8 weeks.
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Progressive Training Plan (8 Weeks) Phase I (Weeks 1-4): ROM & Early Activation:
Phase II (Weeks 5-8): Strengthening & Functional Training:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Wolf Motor Function Test
Tidsramme: The assesment will be done at baseline and after completion of 8 weeks.
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The Wolf Motor Function Test (WMFT) is a standardized tool for assessing upper limb motor function in stroke survivors (Wolf et al., 2001).
It includes 17 tasks: 15 timed functional activities (e.g., lifting objects, stacking) and 2 strength measures (grip and pinch).
It evaluates movement speed, function, and quality, with performance rated on a 6-point scale (0-5) and faster times indicating better ability.
The WMFT has high reliability (ICC > 0.90) and strong validity, correlating well with FMA and ARAT.
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The assesment will be done at baseline and after completion of 8 weeks.
|
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Fugl-Meyer Assessment - Upper Extremity
Tidsramme: The assesment will be done at baseline and after completion of 8 weeks.
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The Fugl-Meyer Assessment (FMA) is a widely used tool to measure motor impairment after stroke (Fugl-Meyer et al., 1975).
It evaluates upper limb function including reflexes, coordination, and voluntary movement of the shoulder, elbow, wrist, and hand.
The total score ranges up to 66, with higher scores indicating better motor recovery.
Each item is scored from 0 to 2, and the sum reflects overall performance.
It has excellent reliability (ICC > 0.95) and strong validity for tracking motor recovery over time.
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The assesment will be done at baseline and after completion of 8 weeks.
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Nine Hole Peg Test
Tidsramme: The assesment will be done at baseline and after completion of 8 weeks.
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The Nine-Hole Peg Test (NHPT) is a standardized, timed assessment used to measure fine motor dexterity of the upper limb (Mathiowetz et al., 1985).
Participants place and remove nine pegs from a pegboard as quickly as possible, and performance is recorded in seconds.
Lower completion time indicates better dexterity.
It shows high reliability (ICC 0.88-0.99)
and strong validity in stroke and other neurological conditions.
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The assesment will be done at baseline and after completion of 8 weeks.
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Malik AN, Afridi A, Rathore FA. Mobile Health (mHealth) Applications for Stroke Rehabilitation: A mini review. J Pak Med Assoc. 2024 Sep;74(9):1723-1726. doi: 10.47391/JPMA.24-74.
- Cao W, Li A, Kadir AA, Chen J, Chen L, Li Q, Hassan II. Older adult stroke survivors' needs and perspectives of a stroke app: a qualitative study. BMC Geriatr. 2025 Mar 29;25(1):212. doi: 10.1186/s12877-025-05849-1.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UBAS/ERB/26/04/036 Haziqa
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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