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Clinical Trials/NCT04266782
NCT04266782
Completed
Not Applicable

ParKinWalk: Physical Activity and Long Group-walking for Motor Impairment and Quality of Life in Parkinson's Disease

Università degli Studi di Brescia1 site in 1 country40 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Università degli Studi di Brescia
Enrollment
40
Locations
1
Primary Endpoint
Supervised gait performance dual task gait
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The study will evaluate the impact of exercise training program followed by long-walking onon supervised and unsupervised gait assessment in Parkinson´s disease and control subjects.

Detailed Description

Background: Several studies suggest an impact of physical exercise on walking parameters in Parkinson´s disease (PD) patients. Objective: the present study will evaluate the impact of three months physical exercise training program followed by a group-long walking on motor impairment in PD. Methods: PD patients will be randomized in two arms: one group will be assessed to a training exercise program of three months followed by long-walking in group under the support of physician/physiotherapist and caregivers. A complete motor, cognitive and general assessment will be performed at baseline. The patients will be evaluated under supervised an unsupervised conditions at baseline, before the long-walking, during the walking and after 2 months after the walk.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
February 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Pilotto

Principal Investigator

Università degli Studi di Brescia

Eligibility Criteria

Inclusion Criteria

  • Parkinson´s disease diagnosis
  • stable dopaminergic treatment ( stable dose in the last three months before baseline evaluation)

Exclusion Criteria

  • gait impairment due to other medical conditions
  • impulsive compulsive disorder
  • severe depression

Outcomes

Primary Outcomes

Supervised gait performance dual task gait

Time Frame: Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care.

Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors)

unsupervised gait performance normal gait

Time Frame: Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care.

Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors)

Supervised gait performance normal gait

Time Frame: Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care.

Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors)

Secondary Outcomes

  • Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes(Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- the assessment will be evaluated at baseline and after 6 months of usual care.)
  • Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes(Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- the assessment will be evaluated at baseline and after 6 months of usual care.)

Study Sites (1)

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