Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-18 @ 9:58 AM
Study NCT ID:
NCT07013214
Status:
None
Last Update Posted:
2025-07-22 00:00:00
First Post:
2025-06-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rehabilitation With Dual-task Exercises to Improve Balance in Patients With Parkinson's Disease
Sponsor:
None
Organization:
Study Overview
Official Title:
Rehabilitation Program to Improve Balance in Patients With Parkinson's Disease: Dual-Task Exercise - A Randomized Controlled Clinical Trial
Status:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUAL-PD-RCT
Brief Summary:
The goal of this clinical trial is to learn if a rehabilitative pathway based on dual-task exercise improves balance in patients with Parkinson's disease, compared to a traditional rehabilitation program. It will also investigate the reduction of fall risk, and improvement in autonomy and quality of life.
The main questions it aims to answer are:
* Does dual-task exercise improve balance more effectively than traditional rehabilitation in Parkinson's patients?
* Does dual-task exercise reduce the risk of falls?
* Does dual-task exercise improve patient autonomy in daily activities?
* Does dual-task exercise enhance the overall quality of life for Parkinson's patients? Researchers will compare a dual-task exercise program to a standard rehabilitation program. Both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. The study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. Randomization will be done using dedicated software to ensure unbiased group distribution.
Participants will:
* Have a confirmed diagnosis of Parkinson's disease (Movement Disorder Society criteria).
* Be in an early to moderate stage of the disease (Hoehn and Yahr score \< 3).
* Be over 30 years old.
* Be able to provide informed consent.
* Have a stable medication regimen for at least three months.
Exclusions include:
* Hoehn and Yahr score ≥3.
* Severe cognitive or psychiatric disorders (e.g., dementia).
* Use of interfering medications or treatments.
* Participation in other clinical trials.
* Pregnancy or breastfeeding.
* Need for medication changes during rehabilitation. Evaluations will be conducted at baseline (T=0), after rehabilitation (T=1), and at a two-month follow-up (T=2). Assessments will include the Tinetti Balance and Gait scales, Timed Up and Go (TUG) test, VAS pain scale, TAMPA Scale for Kinesiophobia, Global Perceived Effect (GPE), Barthel Index, EuroQoL-5D-5L, and ABC Scale. UPDRS, Hoehn and Yahr scale, and MOCA Scale will be administered only at baseline (T=0).
The main questions it aims to answer are:
* Does dual-task exercise improve balance more effectively than traditional rehabilitation in Parkinson's patients?
* Does dual-task exercise reduce the risk of falls?
* Does dual-task exercise improve patient autonomy in daily activities?
* Does dual-task exercise enhance the overall quality of life for Parkinson's patients? Researchers will compare a dual-task exercise program to a standard rehabilitation program. Both groups will receive 20 sessions, 2-3 times a week for two months, each lasting 45 minutes. The study will be double-blinded, meaning neither participants nor researchers involved in treatment administration and data collection will know group assignments. Randomization will be done using dedicated software to ensure unbiased group distribution.
Participants will:
* Have a confirmed diagnosis of Parkinson's disease (Movement Disorder Society criteria).
* Be in an early to moderate stage of the disease (Hoehn and Yahr score \< 3).
* Be over 30 years old.
* Be able to provide informed consent.
* Have a stable medication regimen for at least three months.
Exclusions include:
* Hoehn and Yahr score ≥3.
* Severe cognitive or psychiatric disorders (e.g., dementia).
* Use of interfering medications or treatments.
* Participation in other clinical trials.
* Pregnancy or breastfeeding.
* Need for medication changes during rehabilitation. Evaluations will be conducted at baseline (T=0), after rehabilitation (T=1), and at a two-month follow-up (T=2). Assessments will include the Tinetti Balance and Gait scales, Timed Up and Go (TUG) test, VAS pain scale, TAMPA Scale for Kinesiophobia, Global Perceived Effect (GPE), Barthel Index, EuroQoL-5D-5L, and ABC Scale. UPDRS, Hoehn and Yahr scale, and MOCA Scale will be administered only at baseline (T=0).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: