Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP) (KT-DP)
Primary Purpose
Parkinson Disease, Kinesiotaping
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesiotaping
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- Javier Merino Andrés
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kinesiotaping Group
Exercise Group
Arm Description
We used kinesiotaping (gastrocnemius and lumbar back) plus exercise
We used only exercise
Outcomes
Primary Outcome Measures
Berg Test - T0
Berg Test pre-intervention
Berg Test - T1
Berg Test post-intervention two days
Berg Test - T2
Berg Test post-intervention seven days
Tinetti Gait Test - T0
Tinetti Gait Test pre-intervention
Tinetti Gait Test - T1
Tinetti Gait Test post-intervention two days
Tinetti Gait Test - T2
Tinetti Gait Test post-intervention seven days
Up & Go Test - T0
Up & Go Test pre-intervention
Up & Go Test - T1
Up & Go Test post-intervention two days
Up & Go Test - T2
Up & Go Test post-intervention seven days
Parkinson's Disease Questionnaire - T0
Parkinson's Disease Questionnaire pre-intervention
Parkinson's Disease Questionnaire - T1
Parkinson's Disease Questionnaire post-intervention
surface electromyography -T0
surface electromyography pre-intervention
surface electromyography -T1
surface electromyography post-intervention two days
surface electromyography -T2
surface electromyography post-intervention seven days
Secondary Outcome Measures
Full Information
NCT ID
NCT04326647
First Posted
March 24, 2020
Last Updated
March 26, 2020
Sponsor
University of Castilla-La Mancha
1. Study Identification
Unique Protocol Identification Number
NCT04326647
Brief Title
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP)
Acronym
KT-DP
Official Title
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha
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
To analyze the short-term effect of kinesiotaping in balance and gait on Parkinson's disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Kinesiotaping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kinesiotaping Group
Arm Type
Experimental
Arm Description
We used kinesiotaping (gastrocnemius and lumbar back) plus exercise
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
We used only exercise
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
We used kinesiotaping in gastrocnemius and lumbar back
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercises about balance and gait
Primary Outcome Measure Information:
Title
Berg Test - T0
Description
Berg Test pre-intervention
Time Frame
up to week
Title
Berg Test - T1
Description
Berg Test post-intervention two days
Time Frame
up to week
Title
Berg Test - T2
Description
Berg Test post-intervention seven days
Time Frame
up to week
Title
Tinetti Gait Test - T0
Description
Tinetti Gait Test pre-intervention
Time Frame
up to week
Title
Tinetti Gait Test - T1
Description
Tinetti Gait Test post-intervention two days
Time Frame
up to week
Title
Tinetti Gait Test - T2
Description
Tinetti Gait Test post-intervention seven days
Time Frame
up to week
Title
Up & Go Test - T0
Description
Up & Go Test pre-intervention
Time Frame
up to week
Title
Up & Go Test - T1
Description
Up & Go Test post-intervention two days
Time Frame
up to week
Title
Up & Go Test - T2
Description
Up & Go Test post-intervention seven days
Time Frame
up to week
Title
Parkinson's Disease Questionnaire - T0
Description
Parkinson's Disease Questionnaire pre-intervention
Time Frame
up to month
Title
Parkinson's Disease Questionnaire - T1
Description
Parkinson's Disease Questionnaire post-intervention
Time Frame
up to month
Title
surface electromyography -T0
Description
surface electromyography pre-intervention
Time Frame
up to week
Title
surface electromyography -T1
Description
surface electromyography post-intervention two days
Time Frame
up to week
Title
surface electromyography -T2
Description
surface electromyography post-intervention seven days
Time Frame
up to week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Merino Andrés, MsC
Phone
925268800
Ext
5822
Email
Javier.Merino@uclm.es
Facility Information:
Facility Name
Javier Merino Andrés
City
Toledo
ZIP/Postal Code
45006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP)
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