- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07641803
Mirror Therapy Versus Action Observation Therapy on Upper Limb Motor Function, Functional Independence, and Quality Oflife Among Chronic Stroke Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Stroke is a leading cause of long-term disability worldwide and frequently results in persistent upper limb impairments that limit functional independence and participation in daily activities. Despite advances in rehabilitation, many stroke survivors continue to experience deficits in motor control, coordination, dexterity, and upper extremity function, particularly during the chronic phase of recovery. Therefore, identifying effective rehabilitation strategies that promote neuroplasticity and enhance motor recovery remains a priority in stroke rehabilitation.
Mirror Therapy (MT) and Action Observation Therapy (AOT) are neurocognitive rehabilitation interventions that have gained increasing attention because of their potential to facilitate motor recovery through activation of the mirror neuron system. Mirror Therapy involves observation of the reflection of movements performed by the unaffected limb, creating the visual illusion that the affected limb is moving normally. This visual feedback is believed to stimulate motor cortical areas and promote motor relearning. Action Observation Therapy involves observation of goal-directed motor tasks performed by another individual, followed by active imitation of the observed movements. Through observation and execution of actions, AOT is intended to enhance motor planning, motor learning, and cortical reorganization.
Although both interventions have demonstrated potential benefits in stroke rehabilitation, limited evidence exists directly comparing their effectiveness for improving upper limb function, functional independence, and quality of life among individuals with chronic stroke. This study has been designed to address this gap by evaluating and comparing the clinical effects of MT and AOT within a randomized controlled trial framework.
The study will be conducted at Goshe Shifa Hospital, Lahore, Pakistan. Participants diagnosed with chronic stroke (six months or more post-stroke), aged 45-75 years, with mild-to-moderate upper limb motor impairment, will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes.
Participants allocated to the Mirror Therapy group will receive a structured upper limb rehabilitation program utilizing mirror-induced visual feedback. Sessions will include simple upper limb movements, functional activities, and task-specific training performed while observing the mirror reflection of the unaffected limb. Participants allocated to the Action Observation Therapy group will observe videos demonstrating goal-directed upper limb activities and subsequently practice the observed tasks under physiotherapy supervision.
Both interventions will be delivered for six weeks, five sessions per week, with each session lasting approximately 45 minutes. Outcome assessments will be performed at baseline and after completion of the intervention period by assessors blinded to group allocation.
The primary outcomes of interest include upper limb motor function, functional independence, and health-related quality of life. These outcomes will be measured using the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES), Fugl-Meyer Assessment for Upper Extremity (FMA-UE), and Short Form-36 Health Survey (SF-36), respectively.
The study is expected to contribute evidence regarding the comparative effectiveness of two widely used neurorehabilitation approaches and may assist clinicians in selecting appropriate interventions for upper limb rehabilitation in individuals with chronic stroke.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Lahore, Pakistan, 54590
- The University of Lahore Teaching Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Individuals diagnosed with chronic stroke (≥6 months post-stroke).
- Patients with stroke affecting either the left or right upper limb will be included.
- Mild-to-moderate upper limb motor impairment (Fugl-Meyer Upper Extremity Score between 19-55).
- Ability to follow verbal and visual instructions.
- Medically stable with no active comorbidities affecting rehabilitation (Tang et al., 2024).
Exclusion Criteria:
- Severe cognitive or communication impairments prevent task understanding.
- Presence of severe upper limb spasticity or contractures.
- History of severe visual or perceptual deficits (e.g., neglect, hemianopia).
- Uncontrolled epilepsy or active psychiatric disorders.
- Participation in other upper limb rehabilitation programs during the study period.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Mirror Therapy Group
Participants assigned to this group will receive Mirror Therapy in addition to standard physiotherapy.
A mirror will be positioned in the midline so that movements of the unaffected upper limb are reflected, creating the visual illusion that the affected limb is moving normally.
Treatment sessions will last 45 minutes, five days per week for six weeks.
The intervention will include simple joint movements, functional upper limb activities, and task-specific training designed to promote motor recovery, functional independence, and neuroplasticity.
|
Participants assigned to the Mirror Therapy intervention will receive supervised upper limb rehabilitation using mirror-induced visual feedback.
A mirror will be positioned in the participant's midline, allowing observation of the reflection of the unaffected upper limb while the affected limb remains hidden.
Sessions will include simple joint movements, functional tasks, and task-specific activities designed to promote motor relearning and cortical reorganization.
Treatment will be delivered for 45 minutes per session, five days per week, for six weeks, alongside standard physiotherapy.
|
|
Sperimentale: Action Observation Therapy Group
Participants assigned to this group will receive Action Observation Therapy in addition to standard physiotherapy.
Participants will observe videos demonstrating goal-directed upper limb activities and subsequently imitate the observed movements under physiotherapist supervision.
Treatment sessions will last 45 minutes, five days per week for six weeks.
The intervention will include observation, guided imitation, and repetitive practice of functional tasks aimed at improving motor planning, motor execution, upper limb function, and functional independence.
|
Participants assigned to the Action Observation Therapy intervention will observe videos demonstrating goal-directed upper limb activities and subsequently practice the observed movements under physiotherapist supervision.
The intervention consists of an observation phase, guided imitation, and repetitive task practice to facilitate motor learning and neuroplasticity.
Treatment sessions will last 45 minutes and will be conducted five days per week for six weeks in addition to standard physiotherapy.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Upper Limb Motor Function
Lasso di tempo: Baseline and 6 weeks (end of intervention)
|
Upper limb motor function will be assessed using the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES).
Higher scores indicate better upper extremity motor performance and functional ability.
|
Baseline and 6 weeks (end of intervention)
|
|
Upper Extremity Motor Recovery
Lasso di tempo: Baseline and 6 weeks (end of intervention)
|
Motor recovery will be evaluated using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE).
The scale assesses motor impairment, coordination, reflex activity, and voluntary movement, with higher scores indicating improved motor recovery.
|
Baseline and 6 weeks (end of intervention)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Health-Related Quality of Life
Lasso di tempo: Baseline and 6 weeks (end of intervention)
|
Health-related quality of life will be measured using the Short Form-36 Health Survey (SF-36).
The questionnaire evaluates physical and mental health domains, with higher scores representing better perceived health status and quality of life.
|
Baseline and 6 weeks (end of intervention)
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Binks JA, Emerson JR, Scott MW, Wilson C, van Schaik P, Eaves DL. Enhancing upper-limb neurorehabilitation in chronic stroke survivors using combined action observation and motor imagery therapy. Front Neurol. 2023 Mar 2;14:1097422. doi: 10.3389/fneur.2023.1097422. eCollection 2023.
- Effectiveness of Home-Based Mirror Therapy on Enhancing the Upper Limb Sensory- Motor Recovery of Elderly Patients Post-Stroke. Assiut Scientific Nursing Journal, 12(41), 137-149.
- Kim YS, Song JY, Park SH, Lee MM. Effect of functional electrical stimulation-based mirror therapy using gesture recognition biofeedback on upper extremity function in patients with chronic stroke: A randomized controlled trial. Medicine (Baltimore). 2023 Dec 29;102(52):e36546. doi: 10.1097/MD.0000000000036546.
- Tang E, Moran N, Cadman M, Hill S, Sloan C, Warburton E; guideline committee. Stroke rehabilitation in adults: summary of updated NICE guidance. BMJ. 2024 Mar 22;384:q498. doi: 10.1136/bmj.q498. No abstract available.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UOL/IREB/25/09/0032
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Mirror Therapy
-
Centre Hospitalier Universitaire de Saint EtienneSaint-Etienne MétropoleCompletato
-
Chang Gung Memorial HospitalCompletatoIncidente cerebrovascolareTaiwan
-
Universitat Internacional de CatalunyaIscrizione su invitoParalisi cerebrale emiplegica | Terapia del movimento dello specchioSpagna
-
Universidad de AlmeriaCompletato
-
Chang Gung Memorial HospitalReclutamentoIctus | Disturbi cerebrovascolari | Malattie del sistema nervoso centraleTaiwan
-
University of CoimbraFoundation for Science and Technology, PortugalReclutamentoDisturbo da dismorfismo corporeoPortogallo
-
United States Department of DefenseNational Institute of Mental Health (NIMH)Sconosciuto
-
United States Department of DefenseSconosciutoDolore | Amputazione | Arto fantasmaStati Uniti
-
Limacorporate S.p.aAttivo, non reclutante
-
Mayo Hospital LahoreAttivo, non reclutanteCancro al seno | Ricostruzione del senoPakistan