NCT04326647

Brief Summary

To analyze the short-term effect of kinesiotaping in balance and gait on Parkinson's disease

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

March 24, 2020

Last Update Submit

March 26, 2020

Conditions

Outcome Measures

Primary Outcomes (14)

  • Berg Test - T0

    Berg Test pre-intervention

    up to week

  • Berg Test - T1

    Berg Test post-intervention two days

    up to week

  • Berg Test - T2

    Berg Test post-intervention seven days

    up to week

  • Tinetti Gait Test - T0

    Tinetti Gait Test pre-intervention

    up to week

  • Tinetti Gait Test - T1

    Tinetti Gait Test post-intervention two days

    up to week

  • Tinetti Gait Test - T2

    Tinetti Gait Test post-intervention seven days

    up to week

  • Up & Go Test - T0

    Up \& Go Test pre-intervention

    up to week

  • Up & Go Test - T1

    Up \& Go Test post-intervention two days

    up to week

  • Up & Go Test - T2

    Up \& Go Test post-intervention seven days

    up to week

  • Parkinson's Disease Questionnaire - T0

    Parkinson's Disease Questionnaire pre-intervention

    up to month

  • Parkinson's Disease Questionnaire - T1

    Parkinson's Disease Questionnaire post-intervention

    up to month

  • surface electromyography -T0

    surface electromyography pre-intervention

    up to week

  • surface electromyography -T1

    surface electromyography post-intervention two days

    up to week

  • surface electromyography -T2

    surface electromyography post-intervention seven days

    up to week

Study Arms (2)

Kinesiotaping Group

EXPERIMENTAL

We used kinesiotaping (gastrocnemius and lumbar back) plus exercise

Other: Kinesiotaping

Exercise Group

ACTIVE COMPARATOR

We used only exercise

Other: Exercise

Interventions

We used kinesiotaping in gastrocnemius and lumbar back

Kinesiotaping Group

Exercises about balance and gait

Exercise Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javier Merino Andrés

Toledo, 45006, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Javier Merino Andrés, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 30, 2020

Study Start

July 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations