Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Motor-cognitive exercise therapy in the home

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease focused on measuring Motor-cognitive training, Home training

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stockholms Sjukhem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home training

Arm Description

Participants train 3 times weekly in their home environment with help of a digital training app, over a 10-week period.

Outcomes

Primary Outcome Measures

Participant satisfaction with the eHealth intervention

Participants will rate their satisfaction with using a digital survey following each training session. An average value will be calculated. This will measure the feasibility outcome - Acceptability of the intervention.

Participants perceived intensity of the motor exercises

Participants will rate the intensity of the intervention using the Borg Rating of perceived, Exertion Scale (6-20) following each training session. According to this scale, lower numbers signify lower levels of exertion, and higher numbers signify higher levels of exertion. The aim is that participants levels of exertion will lie in the middle range (12-17) This will measure the feasibility outcome - Practicality or Ability to carry out the intervention.

Participants perceived difficulty of the motor-cognitive (dual-task) exercises

Participants will rate the difficulty of the dual-task exercises using a 0-10 scale (higher scores = higher degree of difficulty) following each exercise session and scores will be averaged over the study period following. This will measure the feasibility outcome - Suitability of the intervention.

Participants actual use of the eHealth training tool

Total time logged in to the digital training app will be derived from system and expressed as a percentage of total recommended intervention time. This will measure the feasibility outcome - Demand of the intervention'.

Total number of adverse events during the training sessions

Participants will report all adverse events such as falls or other injuries acquired during the training session, during a once weekly telephone interview. This will measure the feasibility outcome Safety.

Secondary Outcome Measures

Habitual physical activity

Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days

Usual and fast walking speed

10 meter walk test at self-selected and fast speeds respectively

Functional capacity as well as dual task gait ability

Assessed during the 2 minute walk test (2MWT) in single and dual task conditions

Self-reported walk ability

Walk-12 G Questionnaire

Lower extremity function

30 second chair stand test

Balance performance

Mini Balance Evaluation Systems Test (Mini-BESTest)

Self-reported balance confidence

Activity-specific Balance Confidence (ABC) scale

Self-reported difficulties across 8 dimensions of daily living

The Parkinson's Disease Questionnaire -39 (PDQ-39)

Exercise self-efficacy

Swedish Exercise Self-Efficacy Scale (S-ESES)

Executive Function

Attention and psychomotor processing speed will be assessed by the Trail making test (TMT) conditions 2 (letter Sequencing) and 4 (number-Letter Switching (set-shifting)) from Delis-Kaplan Executive Function System (D-KEFS). Results are presented as time in seconds.

Verbal Fluency

Verbal function, initiation & task-set switching will be assessed by the Verbal fluency (Letter Fluency, Category Fluency, and Category Switching) from Delis-Kaplan Executive Function System (D-KEFS). Raw scores are converted to scaled scores.

Full Information

NCT ID

NCT05027620

First Posted

August 12, 2021

Last Updated

May 3, 2022

Sponsor

Stiftelsen Stockholms Sjukhem

1. Study Identification

Unique Protocol Identification Number

NCT05027620

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

October 5, 2021 (Actual)

Primary Completion Date

January 14, 2022 (Actual)

Study Completion Date

January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stiftelsen Stockholms Sjukhem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson Disease, Telerehabilitation, Physical Therapy

Keywords

Motor-cognitive training, Home training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home training

Arm Type

Experimental

Arm Description

Participants train 3 times weekly in their home environment with help of a digital training app, over a 10-week period.

Intervention Type

Other

Intervention Name(s)

Motor-cognitive exercise therapy in the home

Intervention Description

Participants engage in a progressive 10-week exercise program targeted at improving motor and cognitive function. Motor exercises target functional strength, gait and physical activity level. Training sessions occur 3 times weekly and supported by a digital application which has been adapted for people with Parkinson's disease. Weeks 1-2 focus solely on motor exercises. Dual-task (Motor-cognitive) exercises are introduced at week 3 and progressed until week 10. Participants are also encouraged to increase the physical activity levels during the 10 week period. Weekly contact is made using the video function/ telephone with clinical specialists/ researchers. Two home visits will occur, the first one week prior to the intervention and at the 5-week period. Participants receive motivational messaging and reminders via the app during the intervention period.

Primary Outcome Measure Information:

Title

Participant satisfaction with the eHealth intervention

Description

Participants will rate their satisfaction with using a digital survey following each training session. An average value will be calculated. This will measure the feasibility outcome - Acceptability of the intervention.

Time Frame

10-week period.

Title

Participants perceived intensity of the motor exercises

Description

Participants will rate the intensity of the intervention using the Borg Rating of perceived, Exertion Scale (6-20) following each training session. According to this scale, lower numbers signify lower levels of exertion, and higher numbers signify higher levels of exertion. The aim is that participants levels of exertion will lie in the middle range (12-17) This will measure the feasibility outcome - Practicality or Ability to carry out the intervention.

Time Frame

10-week period.

Title

Participants perceived difficulty of the motor-cognitive (dual-task) exercises

Description

Participants will rate the difficulty of the dual-task exercises using a 0-10 scale (higher scores = higher degree of difficulty) following each exercise session and scores will be averaged over the study period following. This will measure the feasibility outcome - Suitability of the intervention.

Time Frame

10-week period.

Title

Participants actual use of the eHealth training tool

Description

Total time logged in to the digital training app will be derived from system and expressed as a percentage of total recommended intervention time. This will measure the feasibility outcome - Demand of the intervention'.

Time Frame

10-week period.

Title

Total number of adverse events during the training sessions

Description

Participants will report all adverse events such as falls or other injuries acquired during the training session, during a once weekly telephone interview. This will measure the feasibility outcome Safety.

Time Frame

10 week period

Secondary Outcome Measure Information:

Title

Habitual physical activity

Description

Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days

Time Frame