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

University Hospital, Angers

Status: Enrolling

Conditions: Spastic Foot

Treatments: Procedure: Neurotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06138418

2022-A01629-34

Details and patient eligibility

About

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.

Full 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 ...)

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Longitudinal cohort study

Experimental group

Description:

Longitudinal cohort study

Treatment:

Procedure: Neurotomy