- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07654582
Effect of Adding Augmented Cues /Hand Stroke Patient (AUGMENTED CUES)
Effect of Adding Augmented Cues to Physical Therapy Intervention on Hand Function Post Stroke Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Stroke is one of the leading causes of long-term disability worldwide and frequently results in impaired hand function, reduced dexterity, decreased grip strength, and limitations in activities of daily living. Conventional physical therapy is commonly used to improve upper extremity function; however, recovery of hand performance remains challenging for many stroke survivors.
Augmented cues provide additional sensory information through visual, auditory, or sensorimotor feedback that may enhance motor learning and neuroplasticity. Incorporating augmented cues into rehabilitation programs may improve patient engagement, increase repetition of task-specific movements, and facilitate functional recovery.
The purpose of this randomized controlled trial is to examine the effectiveness of adding augmented cue-based training to conventional physical therapy intervention in improving hand function among patients with subacute ischemic stroke.
A total of 50 participants meeting the eligibility criteria will be recruited and randomly assigned into two equal groups:
Study Group: Participants will receive augmented cue-based training combined with conventional physical therapy.
Control Group: Participants will receive conventional physical therapy only.
The intervention will be conducted over an eight-week treatment period. Outcome measures will be collected before and after treatment and will include:
- Nine-Hole Peg Test (NHPT) to assess manual dexterity.
- Hand grip strength measured using a hand dynamometer.
- Pressure pain threshold measured using a pressure algometer.
The primary objective is to determine whether the addition of augmented cues results in greater improvement in hand function compared with conventional physical therapy alone. The results may contribute to the development of more effective rehabilitation strategies for individuals recovering from stroke.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Cairo, Egypte
- Faculty of Physical Therapy , Cairo University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- - Male and female patients.
- Age between 40 and 60 years.
- First-ever subacute ischemic stroke.
- Time since stroke between 6 weeks and 6 months.
- Unilateral upper limb involvement.
- Able to understand and follow verbal instructions.
- Medically stable and able to participate in the rehabilitation program.
- Willing to provide informed consent.
Exclusion Criteria:
- - Hemorrhagic stroke.
- Bilateral stroke involvement.
- Severe cognitive impairment or severe aphasia interfering with participation.
- Severe visual or auditory deficits affecting training.
- Severe upper limb spasticity that prevents hand training.
- Other neurological disorders affecting upper limb function.
- Severe musculoskeletal disorders of the upper limb.
- Participation in another rehabilitation trial during the study period.
- Unstable cardiovascular or medical conditions.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: control group
Participants will receive a conventional physical therapy program for hand rehabilitation after stroke.
Treatment will be administered three times per week for eight weeks (24 sessions), with each session lasting 60 minutes and including range of motion exercises, strengthening exercises, stretching, and task-oriented hand training.
|
Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke.
The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training.
Treatment will be provided three times per week for eight weeks (24 sessions).
|
|
Expérimental: musical gloves
articipants will receive the same conventional physical therapy program provided to the control group in addition to MusicGlove training.
Treatment will be administered three times per week for eight weeks (24 sessions).
MusicGlove will provide augmented visual, auditory, and performance feedback during task-specific hand training.
|
Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke.
The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training.
Treatment will be provided three times per week for eight weeks (24 sessions).
MusicGlove is a sensor-based rehabilitation device that provides augmented visual, auditory, and performance feedback during task-specific hand exercises.
Participants perform repetitive thumb-to-finger opposition and grasping movements synchronized with computer-based musical activities.
Training will be provided in addition to conventional physical therapy three times per week for eight weeks.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nine-Hole peg Test (NHPT)
Délai: Baseline and after 8 weeks of treatment
|
Manual dexterity assessed using the Nine-Hole Peg Test.
The time required to place and remove nine pegs will be recorded in seconds.
Lower scores indicate better hand dexterity.
|
Baseline and after 8 weeks of treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
hand grip strength
Délai: Baseline and after 8 weeks of treatment
|
Hand grip strength will be assessed using a calibrated hand dynamometer.
Participants will perform maximal voluntary grip contractions, and the average value of three trials will be recorded in kilograms.
Higher values indicate greater hand strength.
|
Baseline and after 8 weeks of treatment
|
|
pressure pain threshold
Délai: Baseline and after 8 weeks of treatment
|
Pressure pain threshold of the Extensor Carpi Radialis Brevis muscle will be measured using a digital pressure algometer.
Pressure will be applied at a standardized rate until the participant first perceives pain.
Higher values indicate lower pain sensitivity.
|
Baseline and after 8 weeks of treatment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Moshera H Darwish, PHD, Professor of Physical Therapy for Neurology and Neurosurgery Faculty of Physical Therapy Cairo University
- Directeur d'études: mariam m elsayed, phd, Lecturer in department of physical Therapy for Neurology and Neurosurgery Faculty of physical therapy Cairo University
- Directeur d'études: Essam M Abdulwahab, PHD, Professor of Neurology Faculty of Medicine Al-Azhar university
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P.T.REC/012/006310
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .