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

9 juni 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: 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.
Actieve vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Biodex Balance System
Tijdsspanne: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mini-Balance Evaluation Systems Test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bezmialem Vakif University

Medewerkers

Istanbul University - Cerrahpasa

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 juni 2026

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E-83460662-050.04-1593414

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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