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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05971784
Other study ID # 6- PD-Balance-Telereh-RCT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 25, 2023
Est. completion date December 10, 2023

Study information

Verified date September 2023
Source Gazi University
Contact Sefa Eldemir, PT,PhD.
Phone +90 0530 301 91 58
Email sefa.eldemir@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date December 10, 2023
Est. primary completion date October 10, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation Group
The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities
Control Group
The group that will receive an exercise program consisting of balance and walking activities

Locations

Country Name City State
Turkey Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Sivas

Sponsors (2)

Lead Sponsor Collaborator
Gazi University Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Parkins — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Static Balance- Baseline Assessment will be made with a Biodex Balance System Assessment will be conducted before the intervention
Primary Static Balance- Post intervention Assessment will be made with a Biodex Balance System Assessment will be conducted immediately after the intervention
Primary Gait speed- Baseline Assessment will be made with a wearable movement analysis system (G-walk) during gait Assessment will be conducted before the intervention
Primary Gait speed- Post intervention Assessment will be made with a wearable movement analysis system (G-walk) during gait Assessment will be conducted immediately after the intervention
Primary Balance- Baseline Assessment will be made with the Berg Balance Scale Assessment will be conducted before the intervention
Primary Balance- Post intervention Assessment will be made with the Berg Balance Scale Assessment will be conducted immediately after the intervention
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