- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05971784
The Effect of Upper Extremity Telerehabilitation on Balance and Gait
July 25, 2024 updated by: Sefa Eldemir, Gazi University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sivas, Turkey
- Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation group
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.
|
The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities
|
|
Experimental: Control group
The group that will receive a home exercise program consisting of only balance and walking activities
|
The group that will receive an exercise program consisting of balance and walking activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Balance- Baseline
Time Frame: Assessment will be conducted before the intervention
|
Assessment will be made with a Biodex Balance System
|
Assessment will be conducted before the intervention
|
|
Static Balance- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
|
Assessment will be made with a Biodex Balance System
|
Assessment will be conducted immediately after the intervention
|
|
Balance- Baseline
Time Frame: Assessment will be conducted before the intervention
|
Assessment will be made with the Berg Balance Scale
|
Assessment will be conducted before the intervention
|
|
Balance- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
|
Assessment will be made with the Berg Balance Scale
|
Assessment will be conducted immediately after the intervention
|
|
Gait- Baseline
Time Frame: Assessment will be conducted before the intervention
|
Assessment will be made with the Time up and Go Test
|
Assessment will be conducted before the intervention
|
|
Gait- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
|
Assessment will be made with the Time up and Go Test
|
Assessment will be conducted immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2023
Primary Completion (Actual)
May 10, 2024
Study Completion (Actual)
June 10, 2024
Study Registration Dates
First Submitted
July 25, 2023
First Submitted That Met QC Criteria
July 25, 2023
First Posted (Actual)
August 2, 2023
Study Record Updates
Last Update Posted (Actual)
July 26, 2024
Last Update Submitted That Met QC Criteria
July 25, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6- PD-Balance-Telereh-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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