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A 6-year Follow-up Study of the Effect of Neurorehabilitation Training in Patients With Parkinson's Disease

Primary Purpose

Follow up, Parkinson Disease, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Exercise+FU
Active Comparator group Exercise
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

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

  • Somogy Megyei Kaposi Mór Oktató Kórház

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Exercise+FU

Exercise

Controll

Arm Description

Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 6 years.

After 3 weeks of intensive treatment, no special exercises are performed as a control.

No intervention.

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
September 10, 2020
Last Updated
October 13, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04559997
Brief Title
A 6-year Follow-up Study of the Effect of Neurorehabilitation Training in Patients With Parkinson's Disease
Official Title
6-year Follow-up Study of the Effectiveness of Neurorehabilitation Treatment in a Patient With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital

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
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 6 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise+FU
Arm Type
Experimental
Arm Description
Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 6 years.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
After 3 weeks of intensive treatment, no special exercises are performed as a control.
Arm Title
Controll
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Other
Intervention Name(s)
Exercise+FU
Intervention Description
6 years intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
Intervention Type
Other
Intervention Name(s)
Active Comparator group Exercise
Intervention Description
After 3 weeks of intensive therapy, we withdrew treatment and monitored their condition for 6 years and received only hospital base treatment
Primary Outcome Measure Information:
Title
EQ5D-5L
Description
Questionnaire
Time Frame
6 years long
Title
posturography
Description
body sway, Objective measurement of holding instability
Time Frame
6 year-long
Title
Timed up and Go test
Description
Measuring the speed of walking
Time Frame
6 year-long

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
Facility Information:
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=parkinson+rehabilitation
Description
Related Info

Learn more about this trial

A 6-year Follow-up Study of the Effect of Neurorehabilitation Training in Patients With Parkinson's Disease

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