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An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting

Primary Purpose

Stroke Rehabilitation

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
DISKO-tool
Sponsored by
Danderyd Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation focused on measuring Stroke, Rehabilitation, Medical technology

Eligibility Criteria

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

Inclusion Criteria:

  • impaired motor function after stroke limiting activities of daily living but can walk indoors with or without supervision (functional ambulation category[ >FAC 3), can stand without support >2 min and are able to perform a forward reach of >12 cm in standing position,
  • referred to a neuroteam for rehabilitation interventions in the home setting and/or out- patient rehabilitation at Stockholms sjukhem or Rehab Nordost Täby
  • motivated to perform exercises in the home setting with the DISKO-tool and with recurrent supervision by a physiotherapist through video communication.

Exclusion Criteria:

  • cognitive and/or speech impairment, limiting the ability to follow verbal and written training instruction or study information
  • other disabling neurological disorder or other diagnosis prohibiting physical activity necessary when utilizing the DISKO tool
  • impaired vision preventing orientation and reading instructions on a screen
  • sufficient internet access in the home to participate in the intervention

Sites / Locations

  • Department of Rehabilitation Medicine, Danderyd Hospital
  • Stockholms sjukhem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The patient will receive conventional out patient rehabilitation after discharge to the home after stroke. In addition an individualized training program with gamified excercises for motor function will be set and followed up by clincians using video communication, as part of the DISKO-tool. Patients are instructed to train self sufficiently 5 days a week and will be supervised by the treating physiotherapist. The intervention will last for 6 weeks.

Conventional rehabilitation in primary care after discharge to the home after stroke.

Outcomes

Primary Outcome Measures

BESTest -to assess change
Assesses balance

Secondary Outcome Measures

National Institute of Health Stroke Scale- to assess change
Assesses stroke-related neurologic impairments (0p no detected impairment, summed up to 34p max impairment)
Montreal Cognitive Assessment- to assess change
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
Modified Ashworth Scale- to assess change
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Fugle-Meyr for lower and upper extremity- to assess change
Assesses sensory and movement related functions in lower and upper extremity (0p max impairment summed up to 86p max no detected impairment (lower extremity) 126p max no detected impairment (upper extremity)
Functional Ambulation Category- to assess change
Assesses independence in walking 0p nonfunctional, 5p independent Total score 0-5p
6 minutes walk test combined with the RPE-scale- to assess change
Assesses walking endurance in meters walked
Timed Up and Go Test- to assess change
Assesses gait and mobility (timed sek)
Falls Efficacy Scale- to assess change
Assesses self perceived balance in every day life activities rated on an 11 point scale (0p not safe at all 10p completely safe). Total score: 0- 130 p
Barthel Index- to assess change
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
Stroke Impact Scale- to assess change
Assesses self perceived impact of stroke on functioning and disability (domains: strength, hand function, ADL/IADL, Mobility, Commnication, Emotion, Memory/thinking, Participation rated on a 5 point scale (1p maximum impairment/limitation/restriction, 5p minimum impairment/limitation/restriction) Total score 0-100 p/domain calculated using an algorithm

Full Information

First Posted
April 9, 2019
Last Updated
February 9, 2023
Sponsor
Danderyd Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04065568
Brief Title
An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting
Official Title
An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The pandemic. Collected data will presented as a pilot RCT.
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danderyd Hospital
Collaborators
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Equal access to evidence based rehabilitation in the stroke population is a challenge. Home based solutions including telerehabilitation is a promising strategy to meet these needs. However, the tools must be customized for persons with stroke and the technologies developed to serve rehabilitation purposes. The DISKO-tool was developed to enable efficient, continuous training in the home setting with health professional follow ups of training and training results after stroke via video link. The tool has in a preliminary study proved feasible and safe in different phases after stroke. The functional effect of using the DISKO-tool added to conventional rehabilitation in the home setting is yet to be explored. Thus, the aim of this study is to explore the added value of using the DISKO-tool during rehabilitation in the home setting.
Detailed Description
Aim:The DISKO-tool was developed to enable efficient, continuous training in the home setting with health professional follow ups of training and training results after stroke via video link. The tool has in a preliminary study proved feasible and safe in different phases after stroke. The functional effect of using the DISKO-tool added to conventional rehabilitation in the home setting is yet to be explored. Thus, the aim of this study is to explore the added value of using the DISKO-tool during rehabilitation in the home setting. Hypothesis to be tested: Participants who perform 6 weeks of intensive training supported by the DISKO-tool in addition to the regular stroke rehabilitation interventions, gain a higher level of functioning compared to the control group with regular rehabilitation interventions. Study design: A randomized controlled intervention study. Participants and methods: 100 participants will be included in the study 3-6 months after stroke and after informed consent. The participants are recruited from primary care i.e. neuroteam and out-patient rehabilitation in Stockholm, Sweden. The included patients will be randomized to either 1) the intervention group (n=50) or 2) the control group (n=50). Based on previously published results on the BESTtest [14], a significance level of 5% and a power of 80%, 41 patients/treatment arm need to be included. With an expected minimal loss of participants per treatment arm, the study will require 50 patients/treatment arm. After the baseline assessment, the patients will receive a first introduction to the DISKO-tool. Thereafter the DISKO-tool system is set up at the patients' home by the physiotherapist. For safety reasons, space requirements and convenience of the patients, the physiotherapist in dialogue with the patients will select the placement of the screen. During the home visit, the patients will receive a manual and are instructed and guided in how to use the DISKO-tool including turning on the screen, controlling the user interface and performing test exercises. Dates and times for follow-ups by video communication with the physiotherapist are scheduled. After the installation, the physiotherapist will design an individualized training program for each of the patients. The training program will be based on the initial assessments of functioning and disability and the patients' performance of the test exercises. Type and number of exercises per session, level of difficulty and number of repetitions (including proportion of repetitions to the right and left side of the body) will be set. The set training program is thereafter introduced and evaluated during the first follow-up by video communication with the patients. In both groups, patients are instructed to train self-sufficiently 5 days a week and will be supervised by the treating physiotherapist. The intervention will last for 6 weeks. The baseline and final testing will both be performed at the rehabilitation clinics. The follow-ups, by video communication, will be registered by the physiotherapists in standardised logbooks. Data on conventional interventions will be retrieved from medical records. From the DISKO-tool, data regarding number of performed self-training sessions will be retrieved. After the intervention, the physiotherapist's (also after informed consent) and patient's experience and perception of using the DISKO-tool will be assessed in a study specific questionnaire based on the results of the semi-structured interviews performed in the feasibility study that preceded this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Stroke, Rehabilitation, Medical technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled intervention study.
Masking
Outcomes Assessor
Masking Description
Baseline and outcome will be assessed by blinded physiotherapists not involved in the intervention, who will be trained to be synchronized in the assessment procedures and to follow the same standardised protocol to assure consistency both at the Danderyd Hospital and Stockholm Sjukhem site.
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The patient will receive conventional out patient rehabilitation after discharge to the home after stroke. In addition an individualized training program with gamified excercises for motor function will be set and followed up by clincians using video communication, as part of the DISKO-tool. Patients are instructed to train self sufficiently 5 days a week and will be supervised by the treating physiotherapist. The intervention will last for 6 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional rehabilitation in primary care after discharge to the home after stroke.
Intervention Type
Device
Intervention Name(s)
DISKO-tool
Intervention Description
The training program will be based on the initial assessments of functioning and disability and the patients' performance of the test exercises. Type and number of exercises per session, level of difficulty and number of repetitions (including proportion of repetitions to the right and left side of the body) will be set. The set training program is thereafter introduced and evaluated during the first follow-up by video communication with the patients.
Primary Outcome Measure Information:
Title
BESTest -to assess change
Description
Assesses balance
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale- to assess change
Description
Assesses stroke-related neurologic impairments (0p no detected impairment, summed up to 34p max impairment)
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Montreal Cognitive Assessment- to assess change
Description
Assesses mental function (0p max impairment summed up to 30p no detected impairment)
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Modified Ashworth Scale- to assess change
Description
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Fugle-Meyr for lower and upper extremity- to assess change
Description
Assesses sensory and movement related functions in lower and upper extremity (0p max impairment summed up to 86p max no detected impairment (lower extremity) 126p max no detected impairment (upper extremity)
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Functional Ambulation Category- to assess change
Description
Assesses independence in walking 0p nonfunctional, 5p independent Total score 0-5p
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
6 minutes walk test combined with the RPE-scale- to assess change
Description
Assesses walking endurance in meters walked
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Timed Up and Go Test- to assess change
Description
Assesses gait and mobility (timed sek)
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Falls Efficacy Scale- to assess change
Description
Assesses self perceived balance in every day life activities rated on an 11 point scale (0p not safe at all 10p completely safe). Total score: 0- 130 p
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Barthel Index- to assess change
Description
Assesses independence in mobility and personal care (0p dependent 10/15p independent) Total score 0-100p
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Title
Stroke Impact Scale- to assess change
Description
Assesses self perceived impact of stroke on functioning and disability (domains: strength, hand function, ADL/IADL, Mobility, Commnication, Emotion, Memory/thinking, Participation rated on a 5 point scale (1p maximum impairment/limitation/restriction, 5p minimum impairment/limitation/restriction) Total score 0-100 p/domain calculated using an algorithm
Time Frame
T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: impaired motor function after stroke limiting activities of daily living but can walk indoors with or without supervision (functional ambulation category[ >FAC 3), can stand without support >2 min and are able to perform a forward reach of >12 cm in standing position, referred to a neuroteam for rehabilitation interventions in the home setting and/or out- patient rehabilitation at Stockholms sjukhem or Rehab Nordost Täby motivated to perform exercises in the home setting with the DISKO-tool and with recurrent supervision by a physiotherapist through video communication. Exclusion Criteria: cognitive and/or speech impairment, limiting the ability to follow verbal and written training instruction or study information other disabling neurological disorder or other diagnosis prohibiting physical activity necessary when utilizing the DISKO tool impaired vision preventing orientation and reading instructions on a screen sufficient internet access in the home to participate in the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Palmcrantz, PhD
Organizational Affiliation
Danderyd Hosptial
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorgen Borg, Prof
Organizational Affiliation
Danderyd Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elisabet Akesson, Assoc Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erika Franzén, Assoc Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Danderyd Hospital
City
Danderyd
State/Province
Stockholm
ZIP/Postal Code
SE18288
Country
Sweden
Facility Name
Stockholms sjukhem
City
Stockholm
ZIP/Postal Code
SE112 19
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25980861
Citation
Ehn M, Hansson P, Sjolinder M, Boman IL, Folke M, Sommerfeld D, Borg J, Palmcrantz S. Users perspectives on interactive distance technology enabling home-based motor training for stroke patients. Stud Health Technol Inform. 2015;211:145-52.
Results Reference
background
PubMed Identifier
27918220
Citation
Palmcrantz S, Borg J, Sommerfeld D, Plantin J, Wall A, Ehn M, Sjolinder M, Boman IL. An interactive distance solution for stroke rehabilitation in the home setting - A feasibility study. Inform Health Soc Care. 2017 Sep;42(3):303-320. doi: 10.1080/17538157.2016.1253015. Epub 2016 Dec 5.
Results Reference
result

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An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting

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