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A pilot study of an evaluation of a dynamic foot support for wheelchair users with extensor spasms

Evaluation of a foot support for people with extensor spasms (v1)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74115746
Enrollment
6
Registered
2014-05-29
Start date
2014-03-01
Completion date
Unknown
Last updated
2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonic cerebral palsy Nervous System Diseases Dyskinetic cerebral palsy

Interventions

All participants will receive a novel dynamic foot support which will be hinged at the knee and ankle allowing significant knee and foot movement, while maintaining alignment of the foot and providing

Sponsors

Designability -? Bath Institute of Medical Engineering (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Experiences whole body extensor spasms 2. Uses a wheelchair or other specialist seating 3. Is aged 5 years or older 4. Diagnosis of cerebral palsy

Exclusion criteria

Exclusion criteria: 1. At risk of harm from the dynamic foot support, to be determined by the patient's own occupational or physiotherapist in consultation with the project team 2. Concurrent medical interventions likely to cause changes in the extensor spasms during the course of the study 3. Other medical conditions that may cause harm or distress to the participant as a result of using the foot support (The reason for exclusion is so we do not contaminate our results or those of another study with another intervention)

Design outcomes

Primary

MeasureTime frame
CPCHILD questionnaire - an outcome measure used to measure the care givers' perspectives on the health status, comfort, well being, and ease of care giving of children with severe developmental disabilities, and a useful measure of health related quality of life of these children. Dr Unni Narayanan (CPCHILD author) said adults with severe disabilities issues are much the same, therefore this measure can be used with them as well. CP CHILD Questionnaire will be completed at the fitting appointment (visit 2: consent, baseline assessment and delivery) at the beginning and at the review appointment at the end of the study 5 weeks later (visit 3: Final Assessment). This standard questionnaire will take approximately 1 hour to complete at each of these visits.

Secondary

MeasureTime frame
Each of the following outcome measures will be carried out at the fitting appointment (visit 2) and at the review appointment 5 weeks later (visit 3). 1. Data logging (1 hour) ?- each foot support has a built in load cell which measures the force of the spasms and how often the spasms occur. It will send information to a data logger which will produce graphs. This will be measured with the foot support both in the locked static position and unlocked in the dynamic position for 30 minutes each. 2. Pressure mapping (20 minutes) ?- a pressure mat will be positioned on the participant?s seat cushion for 20 minutes. For 10 of these minutes the foot support will be locked and static, and for the other 10 minutes the foot support will be dynamic. The pressures will be continuously recorded on software which will identify peak and mean pressures in both these time periods. 3. Therapist interview (1 hour) -? this interview consists of a number of qualitative questions which are open ended to allow the participant to express their experience and use of the foot support with some direction to allow comparison before and after the evaluation period.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026