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Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease

9 giugno 2026 aggiornato da: Bezmialem Vakif University

The Effects of Telerehabilitation and Face-to-Face LSVT BIG Method on Motor and Non-Motor Symptoms in Individuals With Parkinson Disease

This prospective, randomized controlled trial will enroll 40 individuals with idiopathic PD (Hoehn & Yahr stages 1-3, MoCA ≥21). Participants will be randomly assigned in a 1:1 ratio to either a telerehabilitation LSVT BIG group or a face-to-face LSVT BIG group, with randomization stratified by Hoehn & Yahr stage using a computer-based block randomization system. Both groups will receive the standard LSVT BIG® protocol consisting of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content will include maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. The telerehabilitation group will receive all sessions via synchronous video conferencing under physiotherapist supervision, while the face-to-face group will receive sessions in a clinical setting. Both groups will be assigned home exercise programs in accordance with the LSVT BIG® protocol, and treatment adherence will be monitored throughout the study.

Outcomes will be assessed at baseline, after 4 weeks of treatment, and at 6-month follow-up. Primary outcomes include postural stability and fall risk assessed with the Biodex Balance System (anterior-posterior stability index, mediolateral stability index, general stability index, fall risk index, limits of stability) and motor and non-motor symptom severity assessed with the MDS-UPDRS (Parts I, II, and III). Secondary outcomes include dynamic balance (Mini-BESTest), functional mobility (Timed Up and Go Test, 10-Meter Walk Test), quality of life (PDQ-39), depression (Beck Depression Inventory), sleep quality (Parkinson's Disease Sleep Scale), fatigue (Parkinson Fatigue Scale), cognitive function (MoCA), and treatment satisfaction (Global Rating of Change Scale).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease
  • Hoehn and Yahr stage 1-3
  • Montreal Cognitive Assessment (MoCA) score ≥ 21
  • Ability to use a smartphone, tablet, or computer
  • Access to internet connection and basic digital literacy
  • Participation in activities outside the home at least 3 days per week

Exclusion Criteria:

  • Diagnosis of a neurological condition other than idiopathic Parkinson's disease
  • Change in antiparkinsonian medication regimen during the study period
  • History of deep brain stimulation
  • Visual or hearing impairment that would prevent participation in treatment or assessments
  • Severe cardiovascular, orthopedic, pulmonary, or systemic comorbidity contraindicating exercise
  • Diagnosis of severe depression, psychotic disorder, or uncontrolled psychiatric illness
  • Participation in another structured physiotherapy or rehabilitation program for
  • Parkinson's disease within the last three months

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Face-to-Face LSVT BIG
Participants will receive the standard LSVT BIG® protocol delivered in a clinical setting. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session), including maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercise assignments will be provided in accordance with the standard LSVT BIG® protocol.
Altro: Face-to-Face LSVT BIG
The standard LSVT BIG® protocol will be delivered in a clinical setting by a certified physiotherapist. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content includes maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercises will be assigned on treatment days (once) and non-treatment days (twice daily) in accordance with the standard LSVT BIG® protocol.
Comparatore attivo: Telerehabilitation LSVT BIG
Participants will receive the standard LSVT BIG® protocol delivered via synchronous video conferencing under physiotherapist supervision. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session), including maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercise assignments will be provided in accordance with the standard LSVT BIG® protocol.
Altro: Telerehabilitation LSVT BIG
The standard LSVT BIG® protocol will be delivered via synchronous video conferencing under physiotherapist supervision. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content includes maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercises will be assigned on treatment days (once) and non-treatment days (twice daily) in accordance with the standard LSVT BIG® protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biodex Balance System
Lasso di tempo: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Lasso di tempo: Baseline, Week 4, Month 6
Motor and non-motor symptom severity will be assessed using Parts I, II, and III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Part I evaluates non-motor symptoms, Part II evaluates motor aspects of daily living, and Part III evaluates clinician-rated motor signs. Each item is scored from 0 (normal) to 4 (severe), with higher total scores indicating greater symptom severity.
Baseline, Week 4, Month 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mini-Balance Evaluation Systems Test
Lasso di tempo: Baseline, Week 4, Month 6
Dynamic balance will be assessed using the 14-item Mini-Balance Evaluation Systems Test, evaluating postural responses, anticipatory postural adjustments, dynamic gait, and sensory orientation. Each item is scored from 0 to 2, with a maximum total score of 28. Higher scores indicate better balance performance.
Baseline, Week 4, Month 6
Timed Up and Go Test
Lasso di tempo: Baseline, Week 4, Month 6
Functional mobility and dynamic balance will be assessed by measuring the time (in seconds) required to rise from a chair, walk 3 meters, turn, and return to sitting. Longer completion times indicate poorer functional mobility.
Baseline, Week 4, Month 6
Parkinson's Disease Questionnaire-39
Lasso di tempo: Baseline, Week 4, Month 6
Health-related quality of life will be assessed using the 39-item Parkinson's Disease Questionnaire-39, covering 8 domains. Each item is scored from 0 to 4, with domain scores ranging from 0 to 100. Higher scores indicate worse quality of life.
Baseline, Week 4, Month 6
Beck Depression Inventory
Lasso di tempo: Baseline, Week 4, Month 6
Depressive symptoms will be assessed using the 21-item Beck Depression Inventory. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms.
Baseline, Week 4, Month 6
Parkinson's Disease Sleep Scale
Lasso di tempo: Baseline, Week 4, Month 6
Sleep quality and sleep-related disturbances will be assessed using the 15-item Parkinson's Disease Sleep Scale. Each item is scored on a visual analog scale from 0 to 10. Lower total scores indicate poorer sleep quality.
Baseline, Week 4, Month 6
Parkinson Fatigue Scale
Lasso di tempo: Baseline, Week 4, Month 6
Fatigue severity and its impact on daily functioning will be assessed using the 16-item Parkinson Fatigue Scale. Each item is scored from 1 to 5, with higher total scores indicating greater fatigue.
Baseline, Week 4, Month 6
Montreal Cognitive Assessment
Lasso di tempo: Baseline, Week 4, Month 6
Cognitive function will be assessed using the Montreal Cognitive Assessment, evaluating attention, executive functions, memory, language, visuospatial skills, abstract thinking, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Baseline, Week 4, Month 6
Global Rating of Change Scale
Lasso di tempo: Week 4, Month 6
Patient-perceived change in overall condition will be assessed using the Global Rating of Change Scale. Scores range from -2 (much worse) to +2 (much better), with higher scores indicating greater perceived improvement.
Week 4, Month 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bezmialem Vakif University

Collaboratori

Istanbul University - Cerrahpasa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 giugno 2026

Completamento primario (Stimato)

30 dicembre 2027

Completamento dello studio (Stimato)

30 giugno 2028

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E-83460662-050.04-1593414

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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Malattie rare

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