Obturator Cryoneurotomy for Hip Adductor Spasticity
ConditionSpasticity, Muscle
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorVancouver Island Health Authority
About this trial
The purpose of the study is to measure the effects of obturator nerve cryoneurotomy, on clinical measures in adult (ages 19+) and paediatric (ages 12-18) patients with hip adductor spasticity, who will receive this procedure as a part of their treatment based on the spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Will have cryoneurotomy as part of their standard treatment for spastic hip adductors in VGH spasticity multidisciplinary clinic.
Are at least 12 years of age at the time of the procedure.
Have the ability to attend testing sessions, comply with testing protocols and provide written informed consent.
Are able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
Disqualifiers
Have a history of previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery to the obturator nerve.
Have any other neurological pathology different from that responsible for the spasticity.
Trial population
Patients who are at least 12 years old and will have Cryoneurotomy as a part of their provided medical care will be asked to be enrolled in the study. All patients will be recruited through multidisciplinary spasticity clinic in Victoria General Hospital where spastic patients are referred to this center routinely.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The degree of changes in hip abductors' active range of motion.
any changes in active passive hip abduction range of motion will be measured by trained examiners with a standard goniometer.
Time frame
measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.2
The degree of changes in hip abductors' maximum passive range of motion.
any changes in maximum passive hip abduction range of motion will be measured by trained examiners with a standard goniometer
Time frame
measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.3
The degree of changes in hip abductors' spasticity
any changes in hip abduction will be measured based on Modified Ashworth Scale, which has 6 scores (from 0 which means no spasticity to 4 which means the highest degree of the spasticity).
Time frame
measurement will be done at baseline, 1 month after having Cryoneurotomy and then every 3 months up to one year.4
The degree of changes in inter knees distance at maximum passive hip abduction range of motion
The measurement will be done by measure tape and based on centimetre scale
Time frame
It will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to 12 monthsSecondary outcomes
1
Any changes in the ability to perform hygienic care related to degree of adductor muscles spasticity
The assessment will be based on a four-point scale: 0 means relatively easy and 3 means with severe difficulty (Viel et al.,2002)
Time frame
The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.2
Any changes in 10-meter walk test.
Patients will be asked to walk in a designed area for 10 meter and twice. the result will be average time of 2 rounds and will be recorded as second.
Time frame
The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.3
Any changes in patients' gait based on the physician's observation and the patient's perception.
The gait will be scored based on a 4-point scale: 0 will be assigned to patients with no difficulty in walking and 3 will be assigned to the patients who are unable to walk (Viel et al.,2002)
Time frame
The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.4
Any changes in degree of pain if they have any.
Patients will be asked if they have any related pain and to score it based on 10-point scale, which 0means no pain and 10 means the worst pain that they ever experienced
Time frame
The assessment will be done at baseline, 1 month after cryoneurotomy and then every 3 months up to one year.Sponsors and contacts
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Source ClinicalTrials.gov