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| Name | Class |
|---|---|
| Istanbul University - Cerrahpasa | OTHER |
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This prospective, randomized controlled trial will enroll 40 individuals with idiopathic PD (Hoehn & Yahr stages 1-3, MoCA ā„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 BIGĀ® 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 BIGĀ® 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-Face LSVT BIG | Active Comparator | Participants will receive the standard LSVT BIGĀ® 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 BIGĀ® protocol. |
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| Telerehabilitation LSVT BIG | Active Comparator | Participants will receive the standard LSVT BIGĀ® 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 BIGĀ® protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-Face LSVT BIG | Other | The standard LSVT BIGĀ® 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 BIGĀ® protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Biodex Balance System | Baseline, Week 4, Month 6 | |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Balance Evaluation Systems Test | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Telerehabilitation LSVT BIG | Other | The standard LSVT BIGĀ® 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 BIGĀ® protocol. |
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| Timed Up and Go Test | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |