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

Parkinson Disease Clinical Trial

Official title:

6-year Follow-up Study of the Effectiveness of Neurorehabilitation Treatment in a Patient With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559997
• Other study ID #: IKEB2020/05
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Follow up
• Parkinson Disease
• Rehabilitation

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

External Links

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