Parkinson DiseaseNCT05971784
The Effect of Upper Extremity Telerehabilitation on Balance and Gait
A study testing Telerehabilitation Group in people with Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily living activities of the patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Telerehabilitation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2023to 10 Jun 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40- 80 years of age
- Having diagnosed with "Parkinson's Disease" by a specialist physician
- Having between 1-3 stages according to the Hoehn and Yahr Scale
- Mini-Mental Test score more than or equal 24
Who cannot join
- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Sivas
About this study
Official title: The Effect of Upper Extremity Telerehabilitation on Balance and Gait in Parkinson's Patients
Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily living activities of the patients. The influence of fine dexterity, reaching, and grasping movements greatly affects the daily living activities of the patients. Medical treatment and surgical approaches are frequently used among the treatment options for PD today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD, together with optimal medical and surgical treatment, form the basis of PD treatment. Recently, it has been stated that intensive and task-specific rehabilitation interventions in the field of physiotherapy and rehabilitation will be more effective than traditional rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which has increased rapidly due to technological developments in recent times, enables the delivery of rehabilitation services to patients in distant places by using communication technologies. For this purpose, it is highly valuable to implement a task-oriented training (TOT) program based on motor learning-based principles, which consists of intense exercise content, through telerehabilitation. Although there are very few studies investigating the effectiveness of telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor performance, activities of daily living, and quality of life are improved. On the other hand, no study has been found showing the effect of upper extremity TOT applied through telerehabilitation on balance and walking. Therefore, there is a need to investigate the effectiveness of telerehabilitation-based TOT exercises on balance and walking.
Read the detailed description
This study is a randomized controlled study. The patients will be randomly divided into two groups exercise and control. Balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. In addition, the exercise group will receive Task-oriented Training (TOT) based telerehabilitation via video conferencing 3 days a week for 6 weeks. TOT will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. As the outcome measures, disease severity, and disability, balance, and gait will be evaluated.
- Conditions
- Parkinson Disease
- Being tested
- Telerehabilitation Group, Control Group
- Keywords
- Parkinson disease, Task oriented training, Balance, Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation GroupOther
The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities
Control GroupOther
The group that will receive an exercise program consisting of balance and walking activities
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | In addition to the exercise program consisting of balance and walking activities, the group will receive task-oriented upper extremity training via telerehabilitation accompanied by a physiotherapist. Receives: Other: Telerehabilitation Group |
| Control group | Experimental | The group that will receive a home exercise program consisting of only balance and walking activities Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance- Baseline
Assessment will be made with a Biodex Balance System
Measured: Assessment will be conducted before the intervention
Static Balance- Post intervention
Assessment will be made with a Biodex Balance System
Measured: Assessment will be conducted immediately after the intervention
Gait- Baseline
Assessment will be made with the Time up and Go Test
Measured: Assessment will be conducted before the intervention
Gait- Post intervention
Assessment will be made with the Time up and Go Test
Measured: Assessment will be conducted immediately after the intervention
Balance- Baseline
Assessment will be made with the Berg Balance Scale
Measured: Assessment will be conducted before the intervention
Balance- Post intervention
Assessment will be made with the Berg Balance Scale
Measured: Assessment will be conducted immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start25 Jul 2023
- Primary completion10 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups as exercise group and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Principal investigator, Sefa Eldemir, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971784
- Sponsor's protocol ID
- 6- PD-Balance-Telereh-RCT
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.
Publications
Eldemir S, Guclu-Gunduz A, Eldemir K, Saygili F, Yilmaz R, Akbostanci MC. The effect of task-oriented circuit training-based telerehabilitation on upper extremity motor functions in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2023 Apr;109:105334. doi: 10.1016/j.parkreldis.2023.105334. Epub 2023 Feb 28.
PubMed 36917914
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Extremity Telerehabilitation on Balance and Gait in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05971784
- Acronym / sponsor ID
- 6- PD-Balance-Telereh-RCT
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Task oriented training, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 2 Aug 2023 (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 (PD) is a disease that affects the upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily living activities of the patients. The influence of fine dexterity, reaching, and grasping movements greatly affects the daily living activities of the patients. Medical treatment and surgical approaches are frequently used among the treatment options for PD today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD, together with optimal medical and surgical treatment, form the basis of PD treatment. Recently, it has been stated that intensive and task-specific rehabilitation interventions in the field of physiotherapy and rehabilitation will be more effective than traditional rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which has increased rapidly due to technological developments in recent times, enables the delivery of rehabilitation services to patients in distant places by using communication technologies. For this purpose, it is highly valuable to implement a task-oriented training (TOT) program based on motor learning-based principles, which consists of intense exercise content, through telerehabilitation. Although there are very few studies investigating the effectiveness of telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor performance, activities of daily living, and quality of life are improved. On the other hand, no study has been found showing the effect of upper extremity TOT applied through telerehabilitation on balance and walking. Therefore, there is a need to investigate the effectiveness of telerehabilitation-based TOT exercises on balance and walking.
Detailed description
This study is a randomized controlled study. The patients will be randomly divided into two groups exercise and control. Balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. In addition, the exercise group will receive Task-oriented Training (TOT) based telerehabilitation via video conferencing 3 days a week for 6 weeks. TOT will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. As the outcome measures, disease severity, and disability, balance, and gait will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups as exercise group and control group
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: Telerehabilitation GroupIn addition to the exercise program consisting of balance and walking activities, the group will receive task-oriented upper extremity training via telerehabilitation accompanied by a physiotherapist. |
| Control group | Experimental | Other: Control GroupThe group that will receive a home exercise program consisting of only balance and walking activities |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40- 80 years of age
- Having diagnosed with "Parkinson's Disease" by a specialist physician
- Having between 1-3 stages according to the Hoehn and Yahr Scale
- Mini-Mental Test score more than or equal 24
Key exclusion criteria (1 listed)
- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results
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 |
|---|---|---|
| Telerehabilitation GroupThe group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities | Other | Telerehabilitation group |
| Control GroupThe group that will receive an exercise program consisting of balance and walking activities | Other | Control group |
Primary outcome
Static Balance- Baseline
Time frame: Assessment will be conducted before the intervention
Assessment will be made with a Biodex Balance System
Static Balance- Post intervention
Time frame: Assessment will be conducted immediately after the intervention
Assessment will be made with a Biodex Balance System
Gait- Baseline
Time frame: Assessment will be conducted before the intervention
Assessment will be made with the Time up and Go Test
Gait- Post intervention
Time frame: Assessment will be conducted immediately after the intervention
Assessment will be made with the Time up and Go Test
Balance- Baseline
Time frame: Assessment will be conducted before the intervention
Assessment will be made with the Berg Balance Scale
Balance- Post intervention
Time frame: Assessment will be conducted immediately after the intervention
Assessment will be made with the Berg Balance Scale
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 26 Jul 2024.
- Results publication: PubMed 36917914Eldemir S, Guclu-Gunduz A, Eldemir K, Saygili F, Yilmaz R, Akbostanci MC. The effect of task-oriented circuit training-based telerehabilitation on upper extremity motor functions in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2023 Apr;109:105334. doi: 10.1016/j.parkreldis.2023.105334. Epub 2023 Feb 28.
- Individual participant dataSharing planned: No. There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Group in people with Parkinson Disease, run by Gazi 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 4 inclusion and 1 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 26 Jul 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?
Static Balance- Baseline (time frame: Assessment will be conducted before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05971784, which also lists 1 linked publication.
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 26 Jul 2024.