- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855161
Effectiveness of Rebound Therapy in Parkinson's Patients
December 20, 2023 updated by: Sefa Eldemir, Gazi University
Effectiveness of Rebound Therapy on Balance and Gait in Parkinson's Patients
Today, physiotherapy approaches in Parkinson's Disease (PD) form the basis of optimal treatment together with medical and surgical treatment.
It is stated that various rehabilitation interventions may be effective in the field of physiotherapy.
The frequently preferred among these rehabilitation interventions is the conventional treatment approach.
In the conventional treatment, various exercises are preferred to improve balance and walking, as well as stretching and strengthening.
On the other hand, rebound therapy require strong integration of the neuromuscular system and provide more active use of lower extremity muscle strength.
Rebound therapy have been shown to be effective in improving balance in many neurological disease groups, but there is very little study on rebound therapy in PD.
It was shown that rebound therapy improve proprioceptive sense, joint range of motion and quality of life.
On the other hand, no study has been found showing its effect on balance and walking.
Therefore, there is a need to investigate the effectiveness of rebound therapy 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 as rebound and control.
The rebound group will perform exercises on a trampoline, consisting of 15 minutes of trunk and extremity stretching, 10 minutes of walking, and approximately 30 minutes of task-oriented exercises, twice a week for six weeks.
While the control group will follow the same program as the rebound group, they will only perform task-oriented exercises on a stable surface, unlike the rebound group.
As the outcome measures, disease severity and disability, balance, and gait performance will be evaluated.
Study Type
Interventional
Enrollment (Actual)
17
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
-
-
-
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
The group that will perform exercises on a stable surface.
|
Participants will receive exercise-based training on a stable surface
|
|
Experimental: Rebound therapy
The group that will perform exercises on a trampoline.
|
Participants will receive exercise-based training on a trampoline
|
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 the 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 the Biodex Balance System
|
Assessment will be conducted immediately after the intervention
|
|
Gait speed- Baseline
Time Frame: Assessment will be conducted before the intervention
|
Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait
|
Assessment will be conducted before the intervention
|
|
Gait speed- Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
|
Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait
|
Assessment will be conducted immediately after the intervention
|
|
Knee strength- Baseline
Time Frame: Assessment will be conducted before the intervention
|
Assessment will be made with an isokinetic dynamometer (Cybex Humac Norm Testing and Rehabilitation System, CSMI, USA)
|
Assessment will be conducted before the intervention
|
|
Knee strength-Post intervention
Time Frame: Assessment will be conducted immediately after the intervention
|
Assessment will be made with an isokinetic dynamometer (Cybex Humac Norm Testing and Rehabilitation System, CSMI, USA)
|
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
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)
April 10, 2023
Primary Completion (Actual)
November 10, 2023
Study Completion (Actual)
December 10, 2023
Study Registration Dates
First Submitted
May 3, 2023
First Submitted That Met QC Criteria
May 3, 2023
First Posted (Actual)
May 11, 2023
Study Record Updates
Last Update Posted (Actual)
December 28, 2023
Last Update Submitted That Met QC Criteria
December 20, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5-PD-Rebound therapy-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make PD 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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