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

Spastic Foot Clinical Trial

— PEPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06138418
• Other study ID #: 2022-A01629-34
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2023
• Source: University Hospital, Angers
• Contact: Jean Michel Lemée, MD PHD
• Phone: 0241353977
• Email: JMLemee[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ...)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spastic Foot

Intervention

Procedure:
• Neurotomy
Surgical treatment of spastic foot

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

Dones I, Nazzi V, Broggi G. The guidelines for the diagnosis and treatment of spasticity. J Neurosurg Sci. 2006 Dec;50(4):101-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Milligan J, Ryan K, Lee J. Demythifier la spasticite en premiere ligne. Can Fam Physician. 2019 Oct;65(10):e422-e428. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of measure	descriptives statistics on percentage of days when connected watch used	18 months
Secondary	Quality of measure	descriptives statistics on percentage of loss of watch	18 months
Secondary	Quality of measure	descriptives statistics on evaluation of acceptability of connected watch.	18 months
Secondary	Walking perimeter improvement delay after plaster cast remove	daily mean after plaster cast remove in which walking perimeter is increasing for 50%	18 months
Secondary	SF-36 Quality of life evolution before vs after surgery	Student t test to evaluate the QOL modications	18 months
Secondary	EQ5D Quality of life evolution before vs after surgery	Student t test to evaluate the QOL modications	18 months
Secondary	Rivermead Quality of life evolution before vs after surgery	Student t test to evaluate the QOL modications	18 months
Secondary	LEFS Quality of life evolution before vs after surgery	Student t test to evaluate the QOL modications	18 months