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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spastic Foot
• Intervention / Treatment: Procedure: Neurotomy

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Michel Lemée, MD PHD; Phone Number: 33 0241353977; Email: JMLemee@chu-angers.fr
• Study Contact Backup: Name: Nicolas Ribault, Resident doctor; Phone Number: 33 0241353988; Email: nicolas.ribault@chu-angers.fr

Study Locations

• France
  • Angers, France, 44933
    • Angers University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Longitudinal cohort study	Procedure: Neurotomy; Surgical treatment of spastic foot; Other Names: Tenotomy

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
• Menz HB, Latt MD, Tiedemann A, Mun San Kwan M, Lord SR. Reliability of the GAITRite walkway system for the quantification of temporo-spatial parameters of gait in young and older people. Gait Posture. 2004 Aug;20(1):20-5. doi: 10.1016/S0966-6362(03)00068-7.
• Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001 Jan;82(1):9-13. doi: 10.1053/apmr.2001.9396.
• Deltombe T, Gustin T. Selective tibial neurotomy in the treatment of spastic equinovarus foot in hemiplegic patients: a 2-year longitudinal follow-up of 30 cases. Arch Phys Med Rehabil. 2010 Jul;91(7):1025-30. doi: 10.1016/j.apmr.2010.04.010.
• Kidd D, Stewart G, Baldry J, Johnson J, Rossiter D, Petruckevitch A, Thompson AJ. The Functional Independence Measure: a comparative validity and reliability study. Disabil Rehabil. 1995 Jan;17(1):10-4. doi: 10.3109/09638289509166622.
• Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. doi: 10.3109/03790799109166684.
• Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.
• Sheean G. The pathophysiology of spasticity. Eur J Neurol. 2002 May;9 Suppl 1:3-9; dicussion 53-61. doi: 10.1046/j.1468-1331.2002.0090s1003.x.
• Wallace D, Duncan PW, Lai SM. Comparison of the responsiveness of the Barthel Index and the motor component of the Functional Independence Measure in stroke: the impact of using different methods for measuring responsiveness. J Clin Epidemiol. 2002 Sep;55(9):922-8. doi: 10.1016/s0895-4356(02)00410-9.
• Milligan J, Ryan K, Lee J. Demythifier la spasticite en premiere ligne. Can Fam Physician. 2019 Oct;65(10):e422-e428. French.
• Nikamp CD, Buurke JH, van der Palen J, Hermens HJ, Rietman JS. Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):798-808. doi: 10.1177/0269215516658337. Epub 2016 Jul 7.
• Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.
• Sankaranarayan H, Gupta A, Khanna M, Taly AB, Thennarasu K. Role of ankle foot orthosis in improving locomotion and functional recovery in patients with stroke: A prospective rehabilitation study. J Neurosci Rural Pract. 2016 Oct-Dec;7(4):544-549. doi: 10.4103/0976-3147.185507.
• King BW, Ruta DJ, Irwin TA. Spastic foot and ankle deformities: evaluation and treatment. Foot Ankle Clin. 2014 Mar;19(1):97-111. doi: 10.1016/j.fcl.2013.10.007.
• Dones I, Nazzi V, Broggi G. The guidelines for the diagnosis and treatment of spasticity. J Neurosurg Sci. 2006 Dec;50(4):101-5.
• Rene F, Casimiro L, Tremblay M, Brosseau L, Lefebvre A, Beaudouin M, Belliveau V, Bergeron LP. Une version canadienne francaise du Lower Extremity Functional Scale (LEFS) : L'Echelle fonctionnelle des membres inferieurs (EFMI), partie I. Physiother Can. 2011 Spring;63(2):242-8. doi: 10.3138/ptc.2010-11F. Epub 2011 Apr 13. French.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: spasticity; neurosurgery; podometer; spastic foot
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: 2022-A01629-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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