Clinical trial NCT04065568: 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
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: Stroke
Rehabilitation
Medical technology
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2019-08-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled intervention study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: BESTest -to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Secondary outcomes:
measure: National Institute of Health Stroke Scale- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Montreal Cognitive Assessment- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Modified Ashworth Scale- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Fugle-Meyr for lower and upper extremity- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Functional Ambulation Category- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: 6 minutes walk test combined with the RPE-scale- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Timed Up and Go Test- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Falls Efficacy Scale- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Barthel Index- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
measure: Stroke Impact Scale- to assess change
timeFrame: T1 (baseline, before start of intervention) T2 (after completion of the 6 week intervention) and T3 (6 months after completion of the intervention)
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
city: Stockholm
country: Sweden
facility: Stockholms sjukhem
Study officials:
affiliation: Danderyd Hosptial
name: Susanne Palmcrantz, PhD
role: STUDY_DIRECTOR
affiliation: Danderyd Hospital
name: Jorgen Borg, Prof
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Elisabet Akesson, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Erika Franzén, Assoc Prof
role: STUDY_DIRECTOR
References:
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.
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.