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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03189680
Other study ID # IKEB0012/2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 11, 2015
Est. completion date June 30, 2017

Study information

Verified date June 2017
Source Somogy Megyei Kaposi Mór Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effects of an unusually highly intensity and individualized sensorimotor and visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility, and postural stability.


Description:

Design: Intervention study

Setting: Outpatient rehabilitation center

Participants: 55 Parkinson's disease (PD) patients completed the trial and 42 serves as comparison healthy controls

Intervention: An initial screening established specific dysfunctions of PD patients with Hoehn-Yahr stage 2-3 who were then randomly assigned to standard care (n = 20) or standard care plus at-limit intensity, individualized agility program (15 sessions, 3 weeks, n = 35).

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 the picture parkinson's disease based on MDS-UPDRS M-EDL, Beck depression score, PDQ-39, EQ5D VAS, Schwab & England scale. 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-demented, stage 2-3 PD patients' clinical symptoms, mobility, and postural stability by functionally meaningful margins.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date June 30, 2017
Est. primary completion date May 31, 2017
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 therapy
3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training

Locations

Country Name City State
Hungary Somogy Megyei Kaposi Mór Teaching Hospital Kaposvár Somogy

Sponsors (2)

Lead Sponsor Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital University Medical Center Groningen

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary EQ5D-5L Questionnaire 0-5 scale (3 week-long, higher number is better)
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