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The Effect of Upper Extremity Telerehabilitation on Balance and Gait

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation Group
Control Group
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Parkinson disease, Task oriented training, Balance, Gait

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation group

Control group

Arm Description

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 a home exercise program consisting of only balance and walking activities

Outcomes

Primary Outcome Measures

Static Balance- Baseline
Assessment will be made with a Biodex Balance System
Static Balance- Post intervention
Assessment will be made with a Biodex Balance System
Gait speed- Baseline
Assessment will be made with a wearable movement analysis system (G-walk) during gait
Gait speed- Post intervention
Assessment will be made with a wearable movement analysis system (G-walk) during gait
Balance- Baseline
Assessment will be made with the Berg Balance Scale
Balance- Post intervention
Assessment will be made with the Berg Balance Scale

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
September 18, 2023
Sponsor
Gazi University
Collaborators
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05971784
Brief Title
The Effect of Upper Extremity Telerehabilitation on Balance and Gait
Official Title
The Effect of Upper Extremity Telerehabilitation on Balance and Gait in Parkinson's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Task oriented training, Balance, Gait

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups as exercise group and control group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
The group that will receive a home exercise program consisting of only balance and walking activities
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Group
Intervention Description
The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The group that will receive an exercise program consisting of balance and walking activities
Primary Outcome Measure Information:
Title
Static Balance- Baseline
Description
Assessment will be made with a Biodex Balance System
Time Frame
Assessment will be conducted before the intervention
Title
Static Balance- Post intervention
Description
Assessment will be made with a Biodex Balance System
Time Frame
Assessment will be conducted immediately after the intervention
Title
Gait speed- Baseline
Description
Assessment will be made with a wearable movement analysis system (G-walk) during gait
Time Frame
Assessment will be conducted before the intervention
Title
Gait speed- Post intervention
Description
Assessment will be made with a wearable movement analysis system (G-walk) during gait
Time Frame
Assessment will be conducted immediately after the intervention
Title
Balance- Baseline
Description
Assessment will be made with the Berg Balance Scale
Time Frame
Assessment will be conducted before the intervention
Title
Balance- Post intervention
Description
Assessment will be made with the Berg Balance Scale
Time Frame
Assessment will be conducted immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sefa Eldemir, PT,PhD.
Phone
+90 0530 301 91 58
Email
sefa.eldemir@gmail.com
Facility Information:
Facility Name
Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Sivas
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sefa Eldemir, PT, PhD.
Phone
+90 0530 301 91 58

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.
Citations:
PubMed Identifier
36917914
Citation
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.
Results Reference
result

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The Effect of Upper Extremity Telerehabilitation on Balance and Gait

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