Clinical trial NCT06138418: Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement with Connected Health Devices (PEPS)
Official title: Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement with Connected Health Devices (PEPS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spastic Foot
Keywords: spasticity
spastic foot
podometer
neurosurgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal evaluation waking ability within activity devices
Primary purpose: OTHER

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 ...)

Eligibility criteria: 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

Primary outcomes:
measure: Walking perimeter changes measured by a connected watch before vs after spastic foot surgery
timeFrame: 18 months
Secondary outcomes:
measure: Diagnostic performance of walking perimeter measure
timeFrame: 18 months
measure: Quality of measure
timeFrame: 18 months
measure: Quality of measure
timeFrame: 18 months
measure: Quality of measure
timeFrame: 18 months
measure: Walking perimeter improvement delay after plaster cast remove
timeFrame: 18 months
measure: SF-36 Quality of life evolution before vs after surgery
timeFrame: 18 months
measure: EQ5D Quality of life evolution before vs after surgery
timeFrame: 18 months
measure: Rivermead Quality of life evolution before vs after surgery
timeFrame: 18 months
measure: LEFS Quality of life evolution before vs after surgery
timeFrame: 18 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: University Hospital, Angers
name: Jean Michel Lemée, MD PHD
role: PRINCIPAL_INVESTIGATOR
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