Clinical trial NCT05027620: Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology
Official title: Continued Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson Disease
Telerehabilitation
Physical Therapy
Keywords: Motor-cognitive training
Home training
Lead sponsor: Stiftelsen Stockholms Sjukhem
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility of a novel motor-cognitive home training intervention using eHealth technology among people with Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

* Neurologist diagnosed Idiopathic PD at least 6 months previous to inclusion.
* Hoehn \& Yahr stages I-III
* Stable in anti-Parkinson medications three months prior to inclusion.
* The ability to walk walk independently indoors without a walking aid.
* The ability to walk continually with/without a walking aid for at least 5 minutes.

Exclusion Criteria:

* Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points).
* Impaired vision and/or impaired communication which hinders participation.
* Major problems with freezing and/or two or more falls in the month previous to inclusion.
* Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise in the home.
* No internet connection in the home.

Primary outcomes:
measure: Participant satisfaction with the eHealth intervention
timeFrame: 10-week period.
measure: Participants perceived intensity of the motor exercises
timeFrame: 10-week period.
measure: Participants perceived difficulty of the motor-cognitive (dual-task) exercises
timeFrame: 10-week period.
measure: Participants actual use of the eHealth training tool
timeFrame: 10-week period.
measure: Total number of adverse events during the training sessions
timeFrame: 10 week period
Secondary outcomes:
measure: Habitual physical activity
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Usual and fast walking speed
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Functional capacity as well as dual task gait ability
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Self-reported walk ability
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Lower extremity function
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Balance performance
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Self-reported balance confidence
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Self-reported difficulties across 8 dimensions of daily living
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Exercise self-efficacy
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Executive Function
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
measure: Verbal Fluency
timeFrame: i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Sjukhem
Study officials:
affiliation: Stockholms sjukhem and Karolinska Institutet
name: Breiffni Leavy, PhD
role: PRINCIPAL_INVESTIGATOR
References: