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OpenTrials
Completed

NCT Number: NCT03193489

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Follow-up

Other

Post-treatment control

Other

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

Control Parkinson group

Other

No treatment.

Primary outcomes

  1. EQ5D-5L

    Time frame: 0-5 scale (2 year-long, higher point is better)

    Questionnaire

  2. posturography

    Time frame: mm (2 year-long, the smaller the mm the better the result)

    body sway, Objective measurement of holding instability

  3. Timed up and Go test

    Time frame: sec (2 year-long, the less time you take the test, the better the result )

    Measuring the speed of walking

Sponsors and collaborators

Lead sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2017
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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