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

Physical Therapy Clinical Trial

Official title:

Continued Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027620
• Other study ID #: 2020-03655
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: May 2022
• Source: Stiftelsen Stockholms Sjukhem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease
• Physical Therapy
• Telerehabilitation

Intervention

Other:
• Motor-cognitive exercise therapy in the home
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.

Locations

Country	Name	City	State
Sweden	Stockholms Sjukhem	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stiftelsen Stockholms Sjukhem

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10-week period.
Primary	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.	10-week period.
Primary	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.	10-week period.
Primary	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'.	10-week period.
Primary	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.	10 week period
Secondary	Habitual physical activity	Measured by the ActiGraph accelerometer model GT3X+ (ActiGraph, Pensacola, FL, US) worn on the hip for seven consecutive days	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Usual and fast walking speed	10 meter walk test at self-selected and fast speeds respectively	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Functional capacity as well as dual task gait ability	Assessed during the 2 minute walk test (2MWT) in single and dual task conditions	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Self-reported walk ability	Walk-12 G Questionnaire	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Lower extremity function	30 second chair stand test	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Balance performance	Mini Balance Evaluation Systems Test (Mini-BESTest)	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Self-reported balance confidence	Activity-specific Balance Confidence (ABC) scale	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Self-reported difficulties across 8 dimensions of daily living	The Parkinson's Disease Questionnaire -39 (PDQ-39)	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	Exercise self-efficacy	Swedish Exercise Self-Efficacy Scale (S-ESES)	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	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.	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)
Secondary	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.	i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)