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Effectiveness of Trampoline Exercises in Parkinson's Patients

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Trampoline exercise
Exercises on a stable surface
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Trampoline exercise, Task oriented training, balance and walking performance

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

  • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Trampoline group

Control group

Arm Description

The group that will perform exercises on a trampoline.

The group that will perform exercises on a stable surface.

Outcomes

Primary Outcome Measures

Static Balance- Baseline
Assessment will be made with the Biodex Balance System
Static Balance- Post intervention
Assessment will be made with the Biodex Balance System
Gait speed- Baseline
Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait
Gait speed- Post intervention
Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait

Secondary Outcome Measures

Full Information

First Posted
May 3, 2023
Last Updated
September 18, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05855161
Brief Title
Effectiveness of Trampoline Exercises in Parkinson's Patients
Official Title
Effectiveness of Trampoline Exercises 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
April 10, 2023 (Actual)
Primary Completion Date
November 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

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
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, trampoline exercises require strong integration of the neuromuscular system and provide more active use of lower extremity muscle strength. Trampoline exercises have been shown to be effective in improving balance in many neurological disease groups, but there is very little study on trampoline exercises in PD. It was shown that trampoline exercises 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 trampoline exercises on balance and walking.
Detailed Description
This study is a randomized controlled study. The patients will be randomly divided into two groups as trampoline and control. The trampoline 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 trampoline group, they will only perform task-oriented exercises on a stable surface, unlike the trampoline group. As the outcome measures, disease severity and disability, balance, and gait performance 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, Trampoline exercise, Task oriented training, balance and walking performance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Trampoline group
Arm Type
Experimental
Arm Description
The group that will perform exercises on a trampoline.
Arm Title
Control group
Arm Type
Experimental
Arm Description
The group that will perform exercises on a stable surface.
Intervention Type
Other
Intervention Name(s)
Trampoline exercise
Intervention Description
Participants will receive exercise-based training on a trampoline
Intervention Type
Other
Intervention Name(s)
Exercises on a stable surface
Intervention Description
Participants will receive exercise-based training on a stable surface
Primary Outcome Measure Information:
Title
Static Balance- Baseline
Description
Assessment will be made with the Biodex Balance System
Time Frame
Assessment will be conducted before the intervention
Title
Static Balance- Post intervention
Description
Assessment will be made with the Biodex Balance System
Time Frame
Assessment will be conducted immediately after the intervention
Title
Gait speed- Baseline
Description
Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait
Time Frame
Assessment will be conducted before the intervention
Title
Gait speed- Post intervention
Description
Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait
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
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sefa Eldemir
Phone
+90 0530 301 91 58
Email
sefa.eldemir@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
31516672
Citation
Daneshvar P, Ghasemi G, Zolaktaf V, Karimi MT. Comparison of the Effect of 8-Week Rebound Therapy-Based Exercise Program and Weight-Supported Exercises on the Range of Motion, Proprioception, and the Quality of Life in Patients with Parkinson's Disease. Int J Prev Med. 2019 Aug 12;10:131. doi: 10.4103/ijpvm.IJPVM_527_18. eCollection 2019.
Results Reference
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Effectiveness of Trampoline Exercises in Parkinson's Patients

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