To investigate the effect of Botulinum toxin treatment on the activity level of people with spastic hemiparese after stroke.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Activity level (measured by the ADL-monitor)
Secondary outcome
- activity level (measured by the SF-36)
- walking ability (measured using instrumented gaitanalysis)
Background summary
Decreased walking ability is one of the major disabilities after stroke. In
patients with spastic hemiparesis main reasons for this disability are
increased tonus and spasms in the hemiplegic limb. In order to decrease the
tonus and spasms and to improve walking ability, the muscles could be localy
treated by injections of botulinum toxin. The effect of this treatment at the
level of the muscle and on the gaitpattern has been investigated previously.
However, untill now, the effect of the injections on activity level is unknown.
Study objective
To investigate the effect of Botulinum toxin treatment on the activity level of
people with spastic hemiparese after stroke.
Study design
Prospective cohort study
Study burden and risks
Botulinum toxin injections and physical examination are part of the regular
treatment.
Gait analysis before and 9 weeks after intervention is part of the regular
intervention. Gait analysis 6 months after intervention is a regular part of
the intervention of childeren having botulinum toxin injections but not of the
intervention of adults after stroke. Because people only have to walk a maximum
of 10 metres about 10 times, this will not be an intense burden. Walking
ability is also registrated during gait analysis.
Questionning the SF-36 is not part of the regular intervention but is expected
not to be an intense burden.
To monitor the activities in daily living is not part of the regular
intervention. Because the activities are monitored using a portable datalogger
(dimension: 10*13*3.5 cm; weight: 650 gram) that is worn in a belt around the
patients waist and a sensor that is put on the thigh for a period of 36 hours,
this will possibly be a burden for the patients.
None of the interventions or measurements will bring any extraordinary risks.
van der Boechorststraat 9
1081 BT Amsterdam
Nederland
van der Boechorststraat 9
1081 BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- age 18 - 65 years
- at least 6 months post-injury
- indication for injections of Botulinum toxin because of spastic gait
Exclusion criteria
- simultaneously undergoing other treatments related to gait training
- wheelchair dependent
- having contractures on the lower limbs
- serious cognitive impairments (not able to learn and/or train anything)
- serious comorbidities related to mobility
- having had injections of botulinum toxin less than 6 months ago
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13524.029.06 |