Spastic Foot
Conditions
Keywords
spasticity, spastic foot, podometer, neurosurgery
Brief summary
PEPS is a 18 months prospective bicentric study on 30 patients with spastic foot. The main objective is to evaluate the mean daily gait perimeter modifications mesured by connected watch, 6 months after spastic equinus foot surgery versus before this surgery. Investigator will lend a connected watch during the first consultation, and the patient will use it during 10 days in order to collect his mean daily gait perimeter. A lot of other tests will be realised in order to caracterize the clinical picture of each patient. After patients will be operated and all caracteristics of the surgery will be collected. Finally, at 6 months appointment, investigator will do the same analysis than first appointment in order to comparate the data for functional prognosis.
Detailed description
The study is proposed to eligible patients after a pluridisciplinar specialised appointment in the Neurosurgery ward, realised by a neurosurgeon, an orthopedist and a PRM physician. After spastic equinus foot diagnosis needed surgery et after patient's consent to the surgery, investigator will proposed to patient to participate at our study. Before surgery, demographic datas, spasticity clinical datas, clinical examination (Ashworth and Penn scale), past treatments are collected. Other investigations are realised : FIM, NFAC, Rivermead mobility index, Lower extremity functional scale, SF36, EQ5D. Gait perimeter are collected by the connected watch, and also with a 10 meters test, the gait perimeter on flat and level ground which is unencumbered by any obstacles, Gaitrite evaluation. Patient will conserved the connected watch during all the study duration. Peroperative datas are collected for each pateints with 3 times. First, before surgery, investigator collect joint range of motion under general anesthesia but without curarization. Second, during surgery, the surgical technique is described, with which nerves and which muscles are treated. Finally, after surgery, investigator will de novo collect joint ranges with the same clinical conditions. At 6 months appointment, routine datas are collected (surgical complications, clinical examination) and also the notified investifations (FIM, NFAC ...), clinical investigations (Gaitrite, connected watch datas ...)
Interventions
PROCEDURENeurotomy
Surgical treatment of spastic foot
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Longitudinal evaluation waking ability within activity devices
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old * Walking patient * Spastic foot surgery indication * Consent form ok * Patient with iOS or Android mobile phone
Exclusion criteria
* Previous spastic surgery * Psychiatric disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking perimeter changes measured by a connected watch before vs after spastic foot surgery | 18 months | Evaluate daily walking perimeter measure measured during 10 days with a connected watch in operated patients between 6 months appointment and pre surgical appointment. Use of appariated Student t test and Spearman test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of measure | 18 months | descriptives statistics on percentage of days when connected watch used |
| Walking perimeter improvement delay after plaster cast remove | 18 months | daily mean after plaster cast remove in which walking perimeter is increasing for 50% |
| SF-36 Quality of life evolution before vs after surgery | 18 months | Student t test to evaluate the QOL modications |
| Diagnostic performance of walking perimeter measure | 18 months | Spearman test to evaluate diagnostic performance of connected watch datas with clinical datas (Gaitrite, 10 m test ...) |
| Rivermead Quality of life evolution before vs after surgery | 18 months | Student t test to evaluate the QOL modications |
| LEFS Quality of life evolution before vs after surgery | 18 months | Student t test to evaluate the QOL modications |
| EQ5D Quality of life evolution before vs after surgery | 18 months | Student t test to evaluate the QOL modications |
Countries
France
Contacts
Primary ContactJean Michel Lemée, MD PHD
Backup ContactNicolas Ribault, Resident doctor
Outcome results
None listed