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

NCT05027620 | Completed

• 1 other identifier: 2020-03655
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Idiopathic Parkinson Disease; Telerehabilitation; Physical Therapy

Keywords

Motor-cognitive training; Home training

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (11)

• Habitual physical activity

  i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

• Usual and fast walking speed

  i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

• Functional capacity as well as dual task gait ability

  i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

• Self-reported walk ability

  i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

• Lower extremity function

  i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training)

Study Arms (1)

Home training

EXPERIMENTAL

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

Other: Motor-cognitive exercise therapy in the home

Interventions

Motor-cognitive exercise therapy in the home OTHER

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.

Home training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hoehn \& Yahr stages I-III
• 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.

You may not qualify if:

• 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.
• Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise in the home.
• No internet connection in the home.

Sponsors & Collaborators

• Stiftelsen Stockholms Sjukhem: lead

Study Sites (1)

Stockholms Sjukhem

Stockholm, 112 19, Sweden

Location

Related Publications (1)

• Sedhed J, Johansson H, Andersson N, Akesson E, Kalbe E, Franzen E, Leavy B. Feasibility of a novel eHealth intervention for Parkinson's disease targeting motor-cognitive function in the home. BMC Neurol. 2024 Apr 5;24(1):114. doi: 10.1186/s12883-024-03614-2.

  PMID: 38580913 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Breiffni Leavy, PhD

  Stockholms sjukhem and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 30, 2021
• Study Start: October 5, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)