This study aimed to test the feasibility of a randomized controlled trial evaluating a low-cost virtual reality glove for upper limb rehabilitation following stroke. The feasibility trial found that while recruitment was reasonable, adherence to the recommended usage of 3 sessions per day was highly variable. Outcome measures showed some improvements in upper limb function for those using the glove compared to usual care, though differences were not always statistically significant. The study demonstrated feasibility for a future definitive randomized controlled trial but suggests adherence may need to be addressed.
Similaire à A low cost virtual reality system for home based rehabilitation of the upper limb following stroke: a randomised controlled feasibility trial
Similaire à A low cost virtual reality system for home based rehabilitation of the upper limb following stroke: a randomised controlled feasibility trial (20)
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A low cost virtual reality system for home based rehabilitation of the upper limb following stroke: a randomised controlled feasibility trial
1. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
A low cost virtual reality system for home
based rehabilitation of the upper limb
following stroke: a randomised controlled
feasibility trial
PJ Standen, Kate Threapleton, Louise Connell, Andy
Richardson, David Brown, Steven Battersby, Fran Platts
A partnership between
Nottinghamshire Healthcare NHS Trust
and the University of Nottingham
2. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Development of equipment
In conjunction with users we developed a low cost intervention for home
use that
• would increase the opportunity for the
amount of therapy required to rehabilitate the
upper limb and fingers following stroke
• was flexible and motivating in order to
improve adherence
• the virtual glove allows capture of the position
of thumb and three fingers and translates into
game play. It is designed to facilitate practice
of movements that underlie everyday tasks
such as grasp and release
3. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Development of games
• Four games each with a different
levels of challenge to keep the
participants motivated to continue to
use the system but to ensure that
they can achieve some success.
• Scores displayed on the screen at the
end of a game.
• A log of when the system is in use is
collected by the computer as well as
what games are being played and
what scores the user obtains.
4. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Feasibility trial
First step in designing a definitive trial which would allow us to
evaluate the effectiveness of the glove
• Can we recruit suitable participants?
• Will they use the glove?
• Can we collect outcome measures and are they appropriate?
5. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Feasibility trial
We approached patients who
• were aged 18 or over who
• were recovering from a stroke
• were no longer receiving any other rehabilitation
• still experiencing problems with their upper limb.
• Recruited from stroke wards City Hospital, ESD and Community
Support Team and Stroke Outreach Service
• Randomly allocated to either the intervention (virtual glove) group
or the control group (usual care).
• Intervention group had the virtual glove, games and a PC in their
homes for a period of 8 weeks .
• They were advised to use the system for 20 mins 3x day (max 56
hours).
6. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Feasibility trial
Baseline and follow up measures of upper limb function at four and
eight weeks
• Wolf motor functions test a measure of upper limb functioning
• 9 hole peg test a test of fine motor co-ordination
• Motor Activity Log how well and how much they use their more
impaired arm to accomplish each of a range of ADL
• Nottingham Extended Activities of Daily Living
• For intervention group only: frequency of using the equipment
7.
8. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Characteristics of sample at baseline
Control group (N=10)
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–
–
–
–
–
•
Mean age = 63.40 (SD = 14.60; range = 35 – 79 yrs)
8 males: 2 females
Time since stroke (weeks): mean = 24; SD = 36.26; median = 12; range = 7 - 126
Type of stroke: 8 ischemic ; 1 haemorrhagic; 1 ‘other’
Side of stroke: 6 left hemisphere , 3 right hemisphere, 1 bilateral
Upper limb affected – 4 left; 6 right ; 7 dominant; 3 non-dominant
Intervention Group (N=17)
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–
–
–
–
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Mean age = 58.94 (SD = 12.03; range = 40 – 82 yrs)
8 males: 9 females
Time since stroke (weeks): mean = 38; SD = 41.28; median = 22; range = 6 - 178
Type of stroke: 13 ischemic; 4 haemorrhagic
Side of stroke: 7 left hemisphere, 9 right hemisphere, 1 bilateral
Upper limb affected – 8 left; 9 right ; 13 dominant; 4 non-dominant
9. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Will they use the glove?
Adherence examined in three ways:
• hours of use,
• days on which it was used
• how many times a day they used it
10. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Will they use the glove?
Percentage of Recommended Use
100
90
80
70
60
50
40
30
20
10
0
%
Percentage
recommende
d time used
Percentage
recommende
d days used
1
2
3
4
8
9
13
17
Participant ID
22
23
24
26
Considerable variation between participants. No-one achieved 100% but P9 who had
glove for only 4 weeks was not far off the recommended use. Two participants used the
glove on every day it was with them, seven on less than half the days. Some people
continued use despite many difficulties in play/psycho-social issues
11. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Will they use the glove?
30
Sessions of use
25
No days max of
1 session
No days max of
2 sessions
No days max of
3 sessions
No days 4+
sessions
Days
20
15
10
5
0
1
2
3
4
8
9
13
17
Participant ID
22
23
24
26
Only 6 participants ever had days with three sessions. Worryingly, 5 had
days with 4 or more sessions. For P9 there were days when use exceeded
90 minutes.
12. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Can we collect outcome measures
and are they appropriate?
22 participants completed outcome measures at 4 weeks and 18 at 8
weeks.
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Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Outcome measures Wolf grip
Change from baseline in intervention group at 4 weeks
significantly (p<0.05) greater than in control group
14. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Outcome measures Nine
hole peg test
Negative change scores = greater improvement. At 4
weeks slightly more improvement in intervention group
but not significant because of outliers
15. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Outcome measures Motor Activity
Log: amount of use
30 items eg Turn on a light with a light switch, use a key to open a door, button a shirt
Participants asked if they have done them during the past week with affected arm
Two scores amount of use and how well they could do the item
At 4 weeks no difference in amount of improvement between the groups. At 8 weeks
intervention group had a significantly (p<0.05) greater improvement than the control
16. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Outcome measures Motor Activity
Log : quality of movement
No difference at 4 weeks. At 8 weeks a greater change in the intervention group
but this doesn’t reach significance
17. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Outcome measures Nottingham
Extended Activities of Daily Living
peg test
Change from baseline in intervention group at 8
weeks greater than in control group but not
significant
“In last few weeks have you managed
to feed yourself, make a hot drink, walk
around outside………?” Four scales:
Mobility, domestic, kitchen, leisure
18. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Conclusion
•
Identifying potential participants time consuming. Once identified, recruitment
reasonable (62% of 47 approached consented).
•
duration of use and on how many days participants used the glove was highly
variable and could fall far short of our recommendations. No one reached the
recommended use but some used the glove on almost every day it was in their
homes. Only 6 participants ever used the glove three times a day but all
participants had days where they used it twice.
•
Adherence low but it’s low for other unsupervised rehabilitation.
•
Eight weeks a long time to ask people to use kit especially if they are trying to
return to their prestroke life.
•
Huge variation in outcomes but inclusion criteria deliberately wide as we had no
idea who this would suit. No reason to drop any of the outcome measures if going
for definitive trial.
19. Collaboration for Leadership in Applied Health Research and Care for
Nottinghamshire, Derbyshire and Lincolnshire
CLAHRC NDL
Acknowledgements
•
•
•
The NIHR CLAHRC – NDL is a partnership between the University of Nottingham
and local NHS organisations and is funded by the NIHR.
Thanks to our expert users for advice on running the trial
Colleagues at NTU including Andy Burton