- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326647
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP) (KT-DP)
March 26, 2020 updated by: University of Castilla-La Mancha
To analyze the short-term effect of kinesiotaping in balance and gait on Parkinson's disease
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
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
-
-
-
Toledo, Spain, 45006
- Javier Merino Andrés
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of stage III PD, according to the Hoehn and Yahr scale.
- Subjects who are in the age range of 50 to 80 years.
- Acceptance of informed consent.
- Not present a musculoskeletal disorder or other neurological disease that interferes with balance and / or walking.
- Not having a diagnosed vestibular disorder.
Exclusion Criteria:
- Diagnosis of parkinsonism o Parkison-Like.
- Taking medications that may interfere with the different variables evaluated.
- Allergy to any component of the bandage.
- Being a pacemaker.
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: Kinesiotaping Group
We used kinesiotaping (gastrocnemius and lumbar back) plus exercise
|
We used kinesiotaping in gastrocnemius and lumbar back
|
|
Active Comparator: Exercise Group
We used only exercise
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Exercises about balance and gait
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Test - T0
Time Frame: up to week
|
Berg Test pre-intervention
|
up to week
|
|
Berg Test - T1
Time Frame: up to week
|
Berg Test post-intervention two days
|
up to week
|
|
Berg Test - T2
Time Frame: up to week
|
Berg Test post-intervention seven days
|
up to week
|
|
Tinetti Gait Test - T0
Time Frame: up to week
|
Tinetti Gait Test pre-intervention
|
up to week
|
|
Tinetti Gait Test - T1
Time Frame: up to week
|
Tinetti Gait Test post-intervention two days
|
up to week
|
|
Tinetti Gait Test - T2
Time Frame: up to week
|
Tinetti Gait Test post-intervention seven days
|
up to week
|
|
Up & Go Test - T0
Time Frame: up to week
|
Up & Go Test pre-intervention
|
up to week
|
|
Up & Go Test - T1
Time Frame: up to week
|
Up & Go Test post-intervention two days
|
up to week
|
|
Up & Go Test - T2
Time Frame: up to week
|
Up & Go Test post-intervention seven days
|
up to week
|
|
Parkinson's Disease Questionnaire - T0
Time Frame: up to month
|
Parkinson's Disease Questionnaire pre-intervention
|
up to month
|
|
Parkinson's Disease Questionnaire - T1
Time Frame: up to month
|
Parkinson's Disease Questionnaire post-intervention
|
up to month
|
|
surface electromyography -T0
Time Frame: up to week
|
surface electromyography pre-intervention
|
up to week
|
|
surface electromyography -T1
Time Frame: up to week
|
surface electromyography post-intervention two days
|
up to week
|
|
surface electromyography -T2
Time Frame: up to week
|
surface electromyography post-intervention seven days
|
up to week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
July 1, 2020
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 30, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- jma002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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