Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement With Connected Health Devices (PEPS)

Study Overview
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Brief Summary
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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
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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 ...)

Official Title
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Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement With Connected Health Devices (PEPS)

Conditions
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Spastic Foot

Intervention / Treatment
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* Procedure: Neurotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal evaluation waking ability within activity devices
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Longitudinal cohort study<br>Longitudinal cohort study | Procedure: Neurotomy<br>* Surgical treatment of spastic foot<br>* Other names: Tenotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking perimeter changes measured by a connected watch before vs after spastic foot surgery | 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of walking perimeter measure | Spearman test to evaluate diagnostic performance of connected watch datas with clinical datas (Gaitrite, 10 m test ...) | 18 months | 
| Quality of measure | descriptives statistics on percentage of days when connected watch used | 18 months | 
| Quality of measure | descriptives statistics on percentage of loss of watch | 18 months | 
| Quality of measure | descriptives statistics on evaluation of acceptability of connected watch. | 18 months | 
| Walking perimeter improvement delay after plaster cast remove | daily mean after plaster cast remove in which walking perimeter is increasing for 50% | 18 months | 
| SF-36 Quality of life evolution before vs after surgery | Student t test to evaluate the QOL modications | 18 months | 
| EQ5D Quality of life evolution before vs after surgery | Student t test to evaluate the QOL modications | 18 months | 
| Rivermead Quality of life evolution before vs after surgery | Student t test to evaluate the QOL modications | 18 months | 
| LEFS Quality of life evolution before vs after surgery | Student t test to evaluate the QOL modications | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spasticity, spastic foot, podometer, neurosurgery