PARKINSON DISEASE (Disorder)NCT07630792
Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease
A study testing Face-to-Face LSVT BIG and Telerehabilitation LSVT BIG in people with PARKINSON DISEASE (Disorder) and Parkinson Disease (PD), Postural Balance, run by Bezmialem Vakif University.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Parkinson Disease (PD), Postural Balance, Parkinson Disease
- What is being tested?
- Face-to-Face LSVT BIG and Telerehabilitation LSVT BIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
- Being tested
- Face-to-Face LSVT BIG, Telerehabilitation LSVT BIG
- Keywords
- Parkinson Disease, LSVT BIG, Telerehabilitation, Motor Symptoms, Non-Motor Symptoms, Balance, Neuroplasticity, Randomized Controlled Trial, Physical Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face LSVT BIGOther
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.
Telerehabilitation LSVT BIGOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face LSVT BIG | Active comparator | 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. Receives: Other: Face-to-Face LSVT BIG |
| Telerehabilitation LSVT BIG | Active comparator | 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. Receives: Other: Telerehabilitation LSVT BIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Balance System
Measured: 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.
Measured: Baseline, Week 4, Month 6
Secondary outcomes (8)
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.
Measured: Baseline, Week 4, Month 6
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630792
- Sponsor's protocol ID
- E-83460662-050.04-1593414
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation and Face-to-Face LSVT BIG Method on Motor and Non-Motor Symptoms in Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT07630792
- Acronym / sponsor ID
- E-83460662-050.04-1593414
- Keywords
- Parkinson Disease, LSVT BIG, Telerehabilitation, Motor Symptoms, Non-Motor Symptoms, Balance, Neuroplasticity, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face LSVT BIG | Active comparator | Other: Face-to-Face LSVT BIGParticipants 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. |
| Telerehabilitation LSVT BIG | Active comparator | Other: Telerehabilitation LSVT BIGParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-Face LSVT BIGThe 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. | Other | Face-to-Face LSVT BIG |
| Telerehabilitation LSVT BIGThe 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. | Other | Telerehabilitation LSVT BIG |
Primary outcome
Biodex Balance System
Time frame: Baseline, Week 4, Month 6
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Time frame: 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.
8 secondary outcomes
Mini-Balance Evaluation Systems Test
Time frame: Baseline, Week 4, Month 6
Timed Up and Go Test
Time frame: Baseline, Week 4, Month 6
Parkinson's Disease Questionnaire-39
Time frame: Baseline, Week 4, Month 6
Beck Depression Inventory
Time frame: Baseline, Week 4, Month 6
Parkinson's Disease Sleep Scale
Time frame: Baseline, Week 4, Month 6
Parkinson Fatigue Scale
Time frame: Baseline, Week 4, Month 6
Montreal Cognitive Assessment
Time frame: Baseline, Week 4, Month 6
Global Rating of Change Scale
Time frame: Week 4, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face LSVT BIG and Telerehabilitation LSVT BIG in people with PARKINSON DISEASE (Disorder) and Parkinson Disease (PD), Postural Balance, run by Bezmialem Vakif University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Balance System (time frame: Baseline, Week 4, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.