NCT04559997

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

6 years

First QC Date

September 10, 2020

Last Update Submit

October 13, 2020

Conditions

Follow upParkinson DiseaseRehabilitation

Keywords

balancePosturograpy

Outcome Measures

Primary Outcomes (3)

  • EQ5D-5L

    Questionnaire

    6 years long

  • posturography

    body sway, Objective measurement of holding instability

    6 year-long

  • Timed up and Go test

    Measuring the speed of walking

    6 year-long

Study Arms (3)

Exercise+FU

EXPERIMENTAL

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

Other: Exercise+FU

Exercise

ACTIVE COMPARATOR

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

Other: Active Comparator group Exercise

Controll

NO INTERVENTION

No intervention.

Interventions

Exercise+FUOTHER

6 years intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training

Exercise+FU
Active Comparator group ExerciseOTHER

After 3 weeks of intensive therapy, we withdrew treatment and monitored their condition for 6 years and received only hospital base treatment

Exercise

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. József Tollár, 7400 Kaposvár, Tallián Gy. u 20-32

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 23, 2020

Study Start

September 1, 2014

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)