Parkinson DiseaseNCT06215898
Investigation of the Effects of LSVT-BlG Protocol on Balance, Gait, Fatigue and Quality of Life in Parkinson's Patients
A study testing LSVT-BIG Group via Telerehabilitation in people with Parkinson Disease, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Treatment for Parkinson's disease is symptom-oriented. Treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LSVT-BIG Group via Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had Parkinson's Disease
- Grade 1-3 on the Hoehn-Yahr Scale
- Stability of drug therapy taken in the last month
- Being in the "ten" period of the patients
- Volunteer to participate in the study
Who cannot join
- Having other neurological, cardiovascular, or orthopedic disorder that may impair mobility have serious hearing and vision problems
- Having an additional neurological or psychiatric illness
- Not having the appropriate equipment for telerehabilitation sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Master's Thesis on the Investigation of the Effects of LSVT-BlG Protocol on Balance, Gait, Fatigue and Quality of Life in Parkinson's Patients
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Treatment for Parkinson's disease is symptom-oriented. Treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions. The LSVT-BIG protocol, a physiotherapy and rehabilitation intervention, aims to overcome the insufficient speed-amplitude regulation that leads to low scaling of motion amplitude at any speed in Parkinson's disease. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and grand walking. Telerehabilitation is a system established for the online delivery of different rehabilitation services via telecommunication, and it has been reported that the LSVT-BIG protocol is a viable method with image-based video conferencing systems.
This study is a randomized controlled trial designed to examine the effect of the LSVT-BIG protocol on balance, gait, fatigue and quality of life. In this direction, thirty-four Parkinson's patients will be divided into two groups by randomization method after a preliminary evaluation including balance, gait, fatigue and quality of life variables. While the telerehabilitation-based LSVT-BIG protocol was applied to the experimental group for four weeks, no physiotherapy and rehabilitation interventions would be applied to the control group in addition to the medical treatment for the same period. At the end of four weeks, both groups will be evaluated again, including balance, gait, fatigue and quality of life variables. Evaluation data will be collected from patients through face-to-face evaluation methods and prepared questionnaires and scales. The obtained data will be evaluated using appropriate statistical methods using the SPSS statistical program.
Read the detailed description
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Motor symptoms include resting tremor, bradykinesia, postural instability, rigidity, postural deformities, and gait disturbances. Non-motor symptoms include cognition and behavioral disorders, autonomic dysfunctions, sleep and sensory disturbances. These symptoms reduce the quality of life of patients and prevent participation in activities of daily living. Treatment for Parkinson's disease is symptom-oriented. These treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions.
Physiotherapy and rehabilitation interventions aim to maximize functional ability, minimize secondary complications, control unwanted side effects of medical treatment and possible motor fluctuations. For this purpose, intervention methods such as aerobic and strengthening exercises, balance and gait training, motor learning and movement strategies and the LSVT-BIG protocol are used in physiotherapy and rehabilitation programs.
LSVT-BIG protocol; derived from the Lee Silverman Voice Treatment protocol developed to improve hypophonia in Parkinson's patients, it is a treatment protocol that includes large amplitude body movements to increase both the speed and amplitude of functional movements. The goal of this protocol is to overcome the insufficient speed-amplitude regulation that leads to low scaling of the amplitude of motion at any given speed. Continuous feedback on motor performance and motion perception training in the protocol is used to offset the reduced gain in motor activities as a result of impaired sensorimotor processing. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and big walking. In the study of Fishel et al., the LSVT-BIG protocol was applied to patients with intermediate Parkinson's disease. According to the results of this study, the LSVT-BIG protocol has a positive effect on balance, fall and walking variables. The study by Farley et al. showed that the LSVT-BIG protocol improved gait. It has been reported that improvement is higher especially in Hoehn Yahr stage 1 Parkinson's patients. The study by Sundaran et al suggests that balance ability in patients with Parkinson's is improved by the LSVT-BIG protocol, as assessed using the Berg Balance Scale.
Telerehabilitation is a system established for the remote delivery of different rehabilitation services via telecommunication. Online access provides advantages in terms of distance, time and cost. By taking the rehabilitation service beyond the hospital process, it allows patients to be treated in a comfortable and familiar environment. Intensive exercise programs such as the LSVT-BIG protocol impose a significant time and economic burden on patients, and there are limitations on access to the clinical setting and the practical applicability of the treatment. It is thought that these limitations can be eliminated by using the telerehabilitation method in practice. It has been reported that the LSVT-BIG protocol with telerehabilitation is a viable method with image-based video conferencing systems. The study by Fırat et al. showed that the LSVT-BIG protocol applied on the basis of telerehabilitation in Parkinson's patients gave positive results on quality of life, motor and non-motor symptoms. However, this study has some limitations such as the absence of a control group, not questioning patient satisfaction, and a small number of participants.
It is important to examine the effects of the LSVT-BIG protocol, which has been encountered in rare studies in the literature, on the motor symptoms of Parkinson's disease, since it is a current treatment approach. Few of these rare studies have used the telerehabilitation method despite the advantages it provides. In this direction, this study was planned to examine the effect of LSVT-BIG protocol applied on the basis of telerehabilitation on balance, gait, fatigue and quality of life in Parkinson's patients.
Thirty-four Parkinson's patients will be included in the study. After the first evaluation, the patients included in the study will be divided into two groups, defined as the experimental and control groups, by randomization method. The telerehabilitation-based LSVT-BIG protocol will be applied to the experimental group for four weeks, four times a week and each session for one hour, accompanied by a physiotherapist and with one-on-one participation. The control group will not be included in any physiotherapy and rehabilitation practices in addition to their basic medical treatments during this period. At the end of four weeks, a final evaluation will be made for both groups. Evaluation data will be collected from patients through face-to-face evaluation methods, questionnaires and scales.
Demographic characteristics of the patients (gender, age, height, body weight, body mass index, duration of the disease, dominant side, occupation, marital status, history, family history and medications used), Hoehn Yahr Stage and UPDRS Score will be recorded. Activity-Specific Balance Confidence Scale and Berg Balance Scale will be used for balance assessment. In addition, one-leg standing test will be applied for the evaluation of static balance and the four-step square test will be applied for the evaluation of dynamic balance. For gait assessment, Dynamic Gait Index and Figure of 8 Walk Test will be applied. Parkinson's Fatigue Scale-16 will be used for fatigue assessment and Parkinson's Disease Questionnaire-8 will be used for quality of life assessment. Telehealth Satisfaction Questionnaire will be applied in order to evaluate the satisfaction of the patient with the physiotherapy and rehabilitation approach applied to the experimental group.
The data obtained will be analyzed using the "Statistical Package for Social Sciences (SPSS)" statistical program.
- Conditions
- Parkinson Disease
- Being tested
- LSVT-BIG Group via Telerehabilitation
- Keywords
- Parkinson's Disease, LSVT-BIG, Balance, Gait, Fatigue, Quality of Life, Telerehabilitation, Telehealth
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSVT-BIG Group via TelerehabilitationOther
An aerobic supervised exercise protocol was implemented four times a week for four weeks in LSVT-BIG Group via a Tele-rehabilitation model.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients with Parkinson's Disease who were in the control group did not receive any interventional application. |
| Exercise Group (LSVT-Big protocol) | Experimental | Patients with Parkinson's disease who were in the exercise group have completed a four-week supervised aerobic exercise protocol via Tele-rehabilitation. Receives: Other: LSVT-BIG Group via Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Assessment
Patients' balance was assessed with Berg Balance Scale
Measured: 4 weeks
Four Step Square Test
Four Step Square Test was used to assess patients' balance.
Measured: 4 weeks
Secondary outcomes (5)
Demographic data form
Information were gathered via a simple data form.
Measured: 4 weeks
Dynamic gait index evaluation
Patients' walking capabilities were evaluated via "Dynamic walking index "
Measured: 4 weeks
Assesment of quality of life
Patients' quality of life was assessed with PQOL-8 questionnaire.Minimum and maximum scores are between 1 and 29,respectively.
Measured: 4 weeks
Fatigue assessment
Patients' fatigue level was assessed with Parkinson Fatigue Questionnaire.Minimum and maximum scores are between 16 and 80,respectively.
Measured: 4 weeks
Assessment of the severity of Parkinson's disease
Patients' fatigue level was assessed with Unified Parkinson's Disease Rating Scale (UPDRS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 May 2023
- Primary completion15 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Ulkü Pekmezci, Izmir Bakircay University
- Investigators
- Alper Tuğral, Ph.D., Study director, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215898
- Sponsor's protocol ID
- IZBU-"PEKMEZCIZEYNEPULKU"-0001
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master's Thesis on the Investigation of the Effects of LSVT-BlG Protocol on Balance, Gait, Fatigue and Quality of Life in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT06215898
- Acronym / sponsor ID
- IZBU-"PEKMEZCIZEYNEPULKU"-0001
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, LSVT-BIG, Balance, Gait, Fatigue, Quality of Life, Telerehabilitation, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 22 Jan 2024 (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.
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Treatment for Parkinson's disease is symptom-oriented. Treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions. The LSVT-BIG protocol, a physiotherapy and rehabilitation intervention, aims to overcome the insufficient speed-amplitude regulation that leads to low scaling of motion amplitude at any speed in Parkinson's disease. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and grand walking. Telerehabilitation is a system established for the online delivery of different rehabilitation services via telecommunication, and it has been reported that the LSVT-BIG protocol is a viable method with image-based video conferencing systems.
This study is a randomized controlled trial designed to examine the effect of the LSVT-BIG protocol on balance, gait, fatigue and quality of life. In this direction, thirty-four Parkinson's patients will be divided into two groups by randomization method after a preliminary evaluation including balance, gait, fatigue and quality of life variables. While the telerehabilitation-based LSVT-BIG protocol was applied to the experimental group for four weeks, no physiotherapy and rehabilitation interventions would be applied to the control group in addition to the medical treatment for the same period. At the end of four weeks, both groups will be evaluated again, including balance, gait, fatigue and quality of life variables. Evaluation data will be collected from patients through face-to-face evaluation methods and prepared questionnaires and scales. The obtained data will be evaluated using appropriate statistical methods using the SPSS statistical program.
Detailed description
Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Motor symptoms include resting tremor, bradykinesia, postural instability, rigidity, postural deformities, and gait disturbances. Non-motor symptoms include cognition and behavioral disorders, autonomic dysfunctions, sleep and sensory disturbances. These symptoms reduce the quality of life of patients and prevent participation in activities of daily living. Treatment for Parkinson's disease is symptom-oriented. These treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions.
Physiotherapy and rehabilitation interventions aim to maximize functional ability, minimize secondary complications, control unwanted side effects of medical treatment and possible motor fluctuations. For this purpose, intervention methods such as aerobic and strengthening exercises, balance and gait training, motor learning and movement strategies and the LSVT-BIG protocol are used in physiotherapy and rehabilitation programs.
LSVT-BIG protocol; derived from the Lee Silverman Voice Treatment protocol developed to improve hypophonia in Parkinson's patients, it is a treatment protocol that includes large amplitude body movements to increase both the speed and amplitude of functional movements. The goal of this protocol is to overcome the insufficient speed-amplitude regulation that leads to low scaling of the amplitude of motion at any given speed. Continuous feedback on motor performance and motion perception training in the protocol is used to offset the reduced gain in motor activities as a result of impaired sensorimotor processing. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and big walking. In the study of Fishel et al., the LSVT-BIG protocol was applied to patients with intermediate Parkinson's disease. According to the results of this study, the LSVT-BIG protocol has a positive effect on balance, fall and walking variables. The study by Farley et al. showed that the LSVT-BIG protocol improved gait. It has been reported that improvement is higher especially in Hoehn Yahr stage 1 Parkinson's patients. The study by Sundaran et al suggests that balance ability in patients with Parkinson's is improved by the LSVT-BIG protocol, as assessed using the Berg Balance Scale.
Telerehabilitation is a system established for the remote delivery of different rehabilitation services via telecommunication. Online access provides advantages in terms of distance, time and cost. By taking the rehabilitation service beyond the hospital process, it allows patients to be treated in a comfortable and familiar environment. Intensive exercise programs such as the LSVT-BIG protocol impose a significant time and economic burden on patients, and there are limitations on access to the clinical setting and the practical applicability of the treatment. It is thought that these limitations can be eliminated by using the telerehabilitation method in practice. It has been reported that the LSVT-BIG protocol with telerehabilitation is a viable method with image-based video conferencing systems. The study by Fırat et al. showed that the LSVT-BIG protocol applied on the basis of telerehabilitation in Parkinson's patients gave positive results on quality of life, motor and non-motor symptoms. However, this study has some limitations such as the absence of a control group, not questioning patient satisfaction, and a small number of participants.
It is important to examine the effects of the LSVT-BIG protocol, which has been encountered in rare studies in the literature, on the motor symptoms of Parkinson's disease, since it is a current treatment approach. Few of these rare studies have used the telerehabilitation method despite the advantages it provides. In this direction, this study was planned to examine the effect of LSVT-BIG protocol applied on the basis of telerehabilitation on balance, gait, fatigue and quality of life in Parkinson's patients.
Thirty-four Parkinson's patients will be included in the study. After the first evaluation, the patients included in the study will be divided into two groups, defined as the experimental and control groups, by randomization method. The telerehabilitation-based LSVT-BIG protocol will be applied to the experimental group for four weeks, four times a week and each session for one hour, accompanied by a physiotherapist and with one-on-one participation. The control group will not be included in any physiotherapy and rehabilitation practices in addition to their basic medical treatments during this period. At the end of four weeks, a final evaluation will be made for both groups. Evaluation data will be collected from patients through face-to-face evaluation methods, questionnaires and scales.
Demographic characteristics of the patients (gender, age, height, body weight, body mass index, duration of the disease, dominant side, occupation, marital status, history, family history and medications used), Hoehn Yahr Stage and UPDRS Score will be recorded. Activity-Specific Balance Confidence Scale and Berg Balance Scale will be used for balance assessment. In addition, one-leg standing test will be applied for the evaluation of static balance and the four-step square test will be applied for the evaluation of dynamic balance. For gait assessment, Dynamic Gait Index and Figure of 8 Walk Test will be applied. Parkinson's Fatigue Scale-16 will be used for fatigue assessment and Parkinson's Disease Questionnaire-8 will be used for quality of life assessment. Telehealth Satisfaction Questionnaire will be applied in order to evaluate the satisfaction of the patient with the physiotherapy and rehabilitation approach applied to the experimental group.
The data obtained will be analyzed using the "Statistical Package for Social Sciences (SPSS)" statistical program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients with Parkinson's Disease who were in the control group did not receive any interventional application. |
| Exercise Group (LSVT-Big protocol) | Experimental | Other: LSVT-BIG Group via TelerehabilitationPatients with Parkinson's disease who were in the exercise group have completed a four-week supervised aerobic exercise protocol via Tele-rehabilitation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have had Parkinson's Disease
- Grade 1-3 on the Hoehn-Yahr Scale
- Stability of drug therapy taken in the last month
- Being in the "ten" period of the patients
- Volunteer to participate in the study
Key exclusion criteria (3 listed)
- Having other neurological, cardiovascular, or orthopedic disorder that may impair mobility have serious hearing and vision problems
- Having an additional neurological or psychiatric illness
- Not having the appropriate equipment for telerehabilitation sessions
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 |
|---|---|---|
| LSVT-BIG Group via TelerehabilitationAn aerobic supervised exercise protocol was implemented four times a week for four weeks in LSVT-BIG Group via a Tele-rehabilitation model. | Other | Exercise Group (LSVT-Big protocol) |
Primary outcome
Berg Balance Assessment
Time frame: 4 weeks
Patients' balance was assessed with Berg Balance Scale
Four Step Square Test
Time frame: 4 weeks
Four Step Square Test was used to assess patients' balance.
5 secondary outcomes
Demographic data form
Time frame: 4 weeks
Dynamic gait index evaluation
Time frame: 4 weeks
Assesment of quality of life
Time frame: 4 weeks
Fatigue assessment
Time frame: 4 weeks
Assessment of the severity of Parkinson's disease
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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. This study is not recruiting at the moment.
Alper Tuğral, Ph.D. study director
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSVT-BIG Group via Telerehabilitation in people with Parkinson Disease, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Berg Balance Assessment (time frame: 4 weeks). 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 22 Jan 2024.