Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Angers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06138418
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Neurotomy
 N/A

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 ...)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Longitudinal evaluation waking ability within activity devicesLongitudinal evaluation waking ability within activity devices
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Spasticity Multidisciplinary Management : QoL and Physical Activity Measurement With Connected Health Devices (PEPS)
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Longitudinal cohort study

Longitudinal cohort study

Procedure: Neurotomy
Surgical treatment of spastic foot
Other Names:
  • Tenotomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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 ...)

    2. Quality of measure [18 months]

      descriptives statistics on percentage of days when connected watch used

    3. Quality of measure [18 months]

      descriptives statistics on percentage of loss of watch

    4. Quality of measure [18 months]

      descriptives statistics on evaluation of acceptability of connected watch.

    5. Walking perimeter improvement delay after plaster cast remove [18 months]

      daily mean after plaster cast remove in which walking perimeter is increasing for 50%

    6. SF-36 Quality of life evolution before vs after surgery [18 months]

      Student t test to evaluate the QOL modications

    7. EQ5D Quality of life evolution before vs after surgery [18 months]

      Student t test to evaluate the QOL modications

    8. Rivermead Quality of life evolution before vs after surgery [18 months]

      Student t test to evaluate the QOL modications

    9. LEFS Quality of life evolution before vs after surgery [18 months]

      Student t test to evaluate the QOL modications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Angers University Hospital Angers France 44933

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Principal Investigator: Jean Michel Lemée, MD PHD, University Hospital, Angers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT06138418
    Other Study ID Numbers:
    • 2022-A01629-34
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University Hospital, Angers
    spasticity
    spastic foot
    podometer
    neurosurgery
    Additional relevant MeSH terms:
    Muscle Spasticity

    Study Results

    No Results Posted as of Nov 18, 2023