Trial Outcomes & Findings for Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT) (NCT NCT01350453)

Results Overview

The MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the amount of use of their hemiplegic arm for each item. Zero is scored if they have not used their affected arm, five is scored when they use their affected as often as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Baseline, Post intervention (three weeks) and 6 months

Results posted on

2019-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	LifeCIT Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care Standard Care: Participants will receive their usual care from their NHS provider.
Overall Study STARTED	11	8
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development and Pilot Evaluation of a Web-supported Programme of Constraint Induced Therapy Following Stroke (LifeCIT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LifeCIT n=9 Participants Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=7 Participants Standard Care: Participants will receive their usual care from their NHS provider.	Total n=16 Participants Total of all reporting groups
Age, Continuous	52.6 years STANDARD_DEVIATION 19.7 • n=93 Participants	63 years STANDARD_DEVIATION 13.2 • n=4 Participants	57.8 years STANDARD_DEVIATION 16.45 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United Kingdom	9 participants n=93 Participants	7 participants n=4 Participants	16 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Post intervention (three weeks) and 6 months

The MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the amount of use of their hemiplegic arm for each item. Zero is scored if they have not used their affected arm, five is scored when they use their affected as often as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.

Outcome measures

Outcome measures
Measure	LifeCIT n=9 Participants Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=7 Participants Standard Care: Participants will receive their usual care from their NHS provider.
Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU) MAL AOU baseline to three weeks	1.02 units on a scale Standard Deviation 0.49	0.06 units on a scale Standard Deviation 0.42
Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU) MAL AOU baseline to six months	0.60 units on a scale Standard Deviation 0.81	0.29 units on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: Baseline, Post Intervention (three weeks) and 6 months

he MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the quality of use of their hemiplegic arm for each item. Zero is scored if they can not use their affected arm, five is scored when they can use their affected arm as well as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.

Outcome measures

Outcome measures
Measure	LifeCIT n=9 Participants Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=7 Participants Standard Care: Participants will receive their usual care from their NHS provider.
Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU) MAL QOU change from baseline to three weeks	1.02 units on a scale Standard Deviation 0.5	0.26 units on a scale Standard Deviation 0.21
Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU) MAL QOU change from baseline to six months	0.6 units on a scale Standard Deviation 0.78	0.23 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline, Post intervention (three weeks), 6 months

The modified WMFT is a valid, widely used measure that scores performance of activities of daily living in a controlled and structured environment he test has 17 items which test a range of functional upper limb tasks (for example turning a key in a lock, folding a towel, retrieving a weight). Each item is scored by the time taken to complete the task, the weight lifted or hand strength as measured by a hand held goniometer. Each item is subsequently scored on a rating scale 'The Functional Ability Scale' (FAS) from 0-5. Zero is scored if the participant does not attempt the task with their hemiplegic arm, and five is scored if the task is completed with a normal movement. The mean score of all items results with a mean FAS score.

Outcome measures

Outcome measures
Measure	LifeCIT n=9 Participants Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=7 Participants Standard Care: Participants will receive their usual care from their NHS provider.
Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) WMFT FAS change from baseline to three weeks	0.35 units on a scale Standard Deviation 0.22	0.02 units on a scale Standard Deviation 0.21
Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) WMFT FAS change from baseline to six months	0.30 units on a scale Standard Deviation 0.47	0.01 units on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: Baseline, Post Intervention (three weeks) and 6 months

The upper extremity domain of the Fugel Myer is a 0-66 point clinical assessed scale where separate Items are scored on a 3-point ordinal scale: 0 = cannot perform, 1 = performs partially, 2 = performs fully. A higher score indicates indicates an increased level of function.

Outcome measures

Outcome measures
Measure	LifeCIT n=9 Participants Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=7 Participants Standard Care: Participants will receive their usual care from their NHS provider.
Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE) FMUE change from baseline to three weeks	5.67 units on a scale Standard Deviation 4.42	2.29 units on a scale Standard Deviation 3.77
Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE) FMUE change from baseline to six months	5.29 units on a scale Standard Deviation 2.43	4.00 units on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: Baseline, Post intervention (three weeks) and 6 months

The Canadian Occupational Performance Measure (COPM) is an individualized client-centered measure designed for use by therapists to detect a change in a client's self-perception of occupational performance over time. The COPM involves a 5-step process within a semi-structured interview conducted by a therapist. The Interview focuses on identifying activities within each performance domain that the client wants, needs, or is expected to perform. They are then asked to rate their performance and satisfaction from 0-10 for each activity identified. A score of 0 indicates they are unable to perform the activity and a score of 10 means they can complete the activity. The same scoring system is used for the COPM Satisfaction assessment with scores ranging from 0-10 and higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	LifeCIT n=9 Participants Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=7 Participants Standard Care: Participants will receive their usual care from their NHS provider.
Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM) COPM Performance change baseline to three weeks	1.07 units on a scale Standard Deviation 1.19	0.77 units on a scale Standard Deviation 1.32
Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM) COPM Performance change baseline to six months	1.69 units on a scale Standard Deviation 1.63	1.24 units on a scale Standard Deviation 2.35
Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM) COPM Satisfaction change baseline to three weeks	1.27 units on a scale Standard Deviation 1.38	1.34 units on a scale Standard Deviation 1.62
Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM) COPM Satisfaction change baseline to six months	1.80 units on a scale Standard Deviation 1.74	1.72 units on a scale Standard Deviation 1.72

Adverse Events

LifeCIT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LifeCIT n=11 participants at risk Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=8 participants at risk Standard Care: Participants will receive their usual care from their NHS provider.
Musculoskeletal and connective tissue disorders Hip fracture	9.1% 1/11 • Number of events 1	0.00% 0/8
Nervous system disorders Second stroke	0.00% 0/11	12.5% 1/8 • Number of events 1

Other adverse events

Other adverse events
Measure	LifeCIT n=11 participants at risk Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities. LifeCIT: Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.	Standard Care n=8 participants at risk Standard Care: Participants will receive their usual care from their NHS provider.
Musculoskeletal and connective tissue disorders Frozen Shoulder	0.00% 0/11	12.5% 1/8 • Number of events 1

Additional Information

Jane Burridge

University of Southampton

Phone: +44(0)2380 598 885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place