Trial Outcomes & Findings for New Technologies in the Rehabilitation of Chronic Stroke (NCT NCT03641651)
NCT ID: NCT03641651
Last Updated: 2022-09-27
Results Overview
Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
4 weeks
Results posted on
2022-09-27
Participant Flow
Participant milestones
| Measure |
Technology Arm
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Technology Arm
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Overall Study
organizational issues at one study site
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 12.5 • n=14 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
|
Region of Enrollment
Switzerland
|
14 participants
n=14 Participants
|
|
Paretic side
Left side
|
9 Participants
n=14 Participants
|
|
Paretic side
Right side
|
5 Participants
n=14 Participants
|
|
Montreal Cognitive assessment (MoCA)
|
24.9 units on a scale
STANDARD_DEVIATION 2.8 • n=14 Participants
|
PRIMARY outcome
Timeframe: 4 weeksAdherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Correlation Between Scheduled and Performed Trainings
|
0.56 correlation coefficient
Interval 0.5 to 0.61
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksobserver based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent)
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Functional Independence Measurement (FIM) Generic Functional Performance
pre-intervention
|
102 units on a scale
Standard Deviation 47.5
|
|
Functional Independence Measurement (FIM) Generic Functional Performance
post-intervention
|
104.5 units on a scale
Standard Deviation 32.5
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksQuestionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items. each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery)
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Stroke Impact Scale (SIS) Recovery
pre-intervention
|
50 units on a scale
Standard Deviation 35
|
|
Stroke Impact Scale (SIS) Recovery
post-intervention
|
65.5 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksMeasures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side. The unit of the measure is the amount of blocks transferred within 60 seconds.
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Box and Block Test
post-intervention
|
1 blocks/60 sec
Standard Deviation 30.8
|
|
Box and Block Test
pre-intervention
|
0 blocks/60 sec
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksObserver based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation)
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Functional Ambulation Categories (FAC)
pre-intervention
|
2 units on a scale
Interval 0.0 to 5.0
|
|
Functional Ambulation Categories (FAC)
post-intervention
|
3.5 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and 4 weekstime needed to walk 10 m with Comfortable walking speed
Outcome measures
| Measure |
Technology Arm
n=12 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
10m Walk Test= TMT Comfortable
pre-intervention
|
28.6 seconds
Standard Deviation 22.9
|
|
10m Walk Test= TMT Comfortable
post-intervention
|
19.0 seconds
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksThe Walking Index consists of the 5 following items: Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
pre-intervention
|
16 units on a scale
Standard Deviation 8.3
|
|
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
post-intervention
|
19 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksObserver based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better
Outcome measures
| Measure |
Technology Arm
n=14 Participants
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
* The training can take place in an outpatient or inpatient setting.
* Training will be organized in individual one-to-one or group session
|
|---|---|
|
Berg Balance Scale (BBS)
pre-intervention
|
32 units on a scale
Standard Deviation 24
|
|
Berg Balance Scale (BBS)
post-intervention
|
39 units on a scale
Standard Deviation 18.8
|
Adverse Events
Technology Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. Markus Wirz
Zurich University of applied sciences
Phone: +41 58 934
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place