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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04559997
Other study ID # IKEB2020/05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date October 1, 2020

Study information

Verified date October 2020
Source Somogy Megyei Kaposi Mór Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date October 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria:

- Parkinson's disease

- Hoenh Yahr scale of 2-3

- Instability problem

Exclusion Criteria:

- Severe heart problems

- Severe demeanor

- Alcoholism

- Drug problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise+FU
6 years intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
Active Comparator group Exercise
After 3 weeks of intensive therapy, we withdrew treatment and monitored their condition for 6 years and received only hospital base treatment

Locations

Country Name City State
Hungary Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár Somogy

Sponsors (1)

Lead Sponsor Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary EQ5D-5L Questionnaire 6 years long
Primary posturography body sway, Objective measurement of holding instability 6 year-long
Primary Timed up and Go test Measuring the speed of walking 6 year-long
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