Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT04065568
Status:
TERMINATED
Last Update Posted:
2023-02-13
First Post:
2019-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting
Sponsor:
Danderyd Hospital
Organization:
Study Overview
Official Title:
An Interactive Distance Solution for Stroke Rehabilitation in the Home Setting
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The pandemic. Collected data will presented as a pilot RCT.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: