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Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease

Primary Purpose

Follow up, Parkinson Disease, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Follow-up
Post-treatment control
Control Parkinson group
Sponsored by
Somogy Megyei Kaposi Mór Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follow up focused on measuring Balance, Posturograpy, quality of life

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parkinson's disease
  • Hoenh Yahr scale of 2-3
  • Instability problem

Exclusion Criteria:

  • Severe heart problems
  • Severe demeanor
  • Alcoholism
  • Drug problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Exercise therapy

    Arm Description

    Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.

    Outcomes

    Primary Outcome Measures

    EQ5D-5L
    Questionnaire
    posturography
    body sway, Objective measurement of holding instability
    Timed up and Go test
    Measuring the speed of walking

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2017
    Last Updated
    April 29, 2020
    Sponsor
    Somogy Megyei Kaposi Mór Teaching Hospital
    Collaborators
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03193489
    Brief Title
    Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
    Official Title
    A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 11, 2015 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Somogy Megyei Kaposi Mór Teaching Hospital
    Collaborators
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Individualization of exercise is recommended but rarely performed in patients with Parkinson's disease (PD). Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation. Objectives: The effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented PD patients with a two-year follow-up. Detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group. Patients were recalled every 3 months after the first intensive examination and one year after a one-year control. The results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality. The treated groups will be divided into two. One Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. The other group does not undergo a special series of exercises after 3 weeks of intensive therapy. Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms. In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL, Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale for Parkinson's Disease. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard. An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. As a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Follow up, Parkinson Disease, Rehabilitation
    Keywords
    Balance, Posturograpy, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise therapy
    Arm Type
    Experimental
    Arm Description
    Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.
    Intervention Type
    Other
    Intervention Name(s)
    Follow-up
    Intervention Type
    Other
    Intervention Name(s)
    Post-treatment control
    Intervention Description
    After 3 weeks of intensive treatment, no special exercises are performed as a control.
    Intervention Type
    Other
    Intervention Name(s)
    Control Parkinson group
    Intervention Description
    No treatment.
    Primary Outcome Measure Information:
    Title
    EQ5D-5L
    Description
    Questionnaire
    Time Frame
    0-5 scale (2 year-long, higher point is better)
    Title
    posturography
    Description
    body sway, Objective measurement of holding instability
    Time Frame
    mm (2 year-long, the smaller the mm the better the result)
    Title
    Timed up and Go test
    Description
    Measuring the speed of walking
    Time Frame
    sec (2 year-long, the less time you take the test, the better the result )

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Parkinson's disease Hoenh Yahr scale of 2-3 Instability problem Exclusion Criteria: Severe heart problems Severe demeanor Alcoholism Drug problems

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/
    Description
    Description Related Info

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    Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease

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