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

NCT ID: NCT04559997

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Follow up Parkinson Disease Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise+FU

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

Group Type EXPERIMENTAL

Exercise+FU

Intervention Type OTHER

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

Exercise

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

Group Type ACTIVE_COMPARATOR

Active Comparator group Exercise

Intervention Type OTHER

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

Controll

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise+FU

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Severe heart problems
* Severe demeanor
* Alcoholism
* Drug problems
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Somogy Megyei Kaposi Mór Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tollár József

Dr. József Tollár, 7400 Kaposvár, Tallián Gy. u 20-32

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, Hungary

Site Status

Countries

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Hungary

Related Links

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Other Identifiers

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IKEB2020/05

Identifier Type: -

Identifier Source: org_study_id

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