Walking Ankle isoKinetic Exercise (WAKE)

Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study

This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to reach a more effective walking activity. This should encourage social participation following discharge from the hospital. The main objective is to evaluate the impact of this 6 weeks program on walking speed.

Study Overview

• Status: Recruiting
• Conditions: Stroke Rehabilitation
• Intervention / Treatment: Other: Rehabilitation program 1; Other: Rehabilitation program 2

Detailed Description

According to HAS, stroke is the leading cause of disability acquired in France. If 90% of patients recover walking, it is often limited with a steady speed around 0.7m/s. This limitation of walking activity is partly related to a decrease in strength associated with more or less significant spasticity. In stroke, this decrease in strength is the result of central impairment. Rehabilitation therefore involves gestural repetition. Mentiplay's review (Mentiplay et al., 2015) showing the predominance of ankle muscle strength in walking activity, we propose a protocol based on repetitive mobilization of this joint during subacute phase to promote awakening control, to limit the loss of muscle strength and thus potentiate the recovery of a more efficient walking. The strength of this study would be to verify the effectiveness of such a program in a large number of patients (5 centers involved). Its originality is to measure the impact of this program on social participation.

The patients will be recruited in 5 centers during their hospitalization, in sub-acute phase. Two groups will be formed: a control group in conventional rehabilitation; an experimental group that will perform 5x/week 300 movements of plantarflexion, dorsiflexion on isokinetic dynamometer (in passive mode, with the intention of producing the greatest possible force). This protocol will take place over 6 weeks.

Follow-up visits will take place at the end of the 6th week (which corresponds to the end of the ankle rehabilitation protocol), 6 months and one year after the beginning of the protocol.

These visits will include a clinical examination, a GaitRite carpet walking test, an isokinetic evaluation of the ankle dorsiflexor muscles strength and a SIPSO self-administered questionnaire (social participation) at 6 months and one year.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Christophe DAVIET, Pr; Phone Number: + 33 5 55 05 65 38; Email: jean-christophe.daviet@unilim.fr

Study Locations

• France
  • Bidart, France, 64210
    • Terminated
    • Reeducation Institute Les Embruns
  • Bordeaux, France, 33000
    • Active, not recruiting
    • University Hospital
  • Brive-la-Gaillarde, France, 19312
    • Not yet recruiting
    • DUBOIS Hospital
    • Contact: Sonia JEDDI; Email: s.jeddi@hotmail.fr
    • Principal Investigator: Sonia Jeddi
  • Limoges, France, 87042
    • Recruiting
    • University Hospital
    • Contact: Jean-Christophe DAVIET, Pr; Phone Number: + 33 5 55 05 65 38; Email: jean-christophe.daviet@unilim.fr
    • Principal Investigator: Jean-Christophe DAVIET
  • Marseille, France, 13009
    • Recruiting
    • University Institute of Rehabilitation Valmante Sud
    • Contact: Laurent BENSOUSSAN, Pr; Phone Number: + 33 4 88 22 86 99; Email: Laurent.bensoussan@ap-hm.fr
    • Principal Investigator: Laurent BENSOUSSAN
  • Noth, France, 23300
    • Not yet recruiting
    • Functional Rehabilitation Center
    • Contact: Alfredo MUSUMECI; Email: alfredo.musumeci@fondationpartageetvie.org
    • Principal Investigator: Alfredo MUSUMECI
  • Poitiers, France, 86021
    • Recruiting
    • University Hospital
    • Contact: Anne JOSSART, Dr; Phone Number: + 33 5 49 44 44 26; Email: Anne.jossart@chu-poitiers.fr
    • Principal Investigator: Romain DAVID

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First stroke,
• Ischemic or hemorrhagic stroke hospitalized in MPR in sub-acute phase (15 days to 3 months)
• Persistent deficiency of foot lifts (Medical Research Council testing: MRC <5)
• Walking alone at least 10 meters with or without technical assistance
• Absence of pain in the lower limb (EVA <2)

Exclusion Criteria:

• Cognitive or phasic disorders that do not make it possible to understand the instructions: Boston Scale BDAE <2
• Gait disorder before stroke
• Fixed stiffness of the ankle (irreducible equine less than 30 °)
• Spasticity too important: Modified Ashworth (MAS) greater than or equal to 4.
• Pregnancy or desire for pregnancy, breastfeeding
• Patient under curatorship or guardianship or under the protection of justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Rehabilitation program 2; Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking. The control group will have a supplement in conventional rehabilitation equal to the additional time of the experimental group.
Experimental: Experimental group	Other: Rehabilitation program 1; Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking. In addition to this conventional rehabilitation, the experimental group will receive an ankle isokinetic program, 5 times a week, for 6 weeks (with a minimum of 25 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	10 m walking speed measured at the end of intervention	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social participation	Social participation will be analyzed by specific questionnaire, the Subjective Index of Physical and Social Outcome (SIPSO) at S26 (26th week) and S52 (52th week).	Week 26, Week 52
Walking spatio-temporal parameters	The parameters will be measured using a treadmill at each assessment (week 0, week 6, week 26, week 52) : the duration of support phase (ms),; the duration of oscillating phase (ms),; the cadence (steps/min),; the step variability.	Week 0, Week 6, Week 26, Week 52
Walking speed	10m speed: measured at week 26 and week 52	Week 26, Week 52
Dorsiflexors strength	Dorsiflexors strength evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and Week 52.	Week 26, Week 52
Use of technical aids to walk and the number of fall	The use of technical aids to walk and the number of falls will be listed in Week 52.	Week 52
Correlations between walking speed /dorsiflexor muscles strength	Correlations between walking speed /dorsiflexor muscles strength at Week 0, Week 6, Week 26 and Week 52 and walking speed/social participation at Week 26 and Week 52. (The dorsiflexor muscles strength will be evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and Week 52. The walking speed over 10m will be measured at Week 0, Week 6, Week 26 and Week52. Social participation will be measured by questionnaire (SIPSO) at Week 26 and Week 52)	Week 0, Week 6, Week 26, Week 52

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Jean-Christophe DAVIET, University Hospital, Limoges

Publications and helpful links

General Publications

• Ferry B, Compagnat M, Yonneau J, Bensoussan L, Moucheboeuf G, Muller F, Laborde B, Jossart A, David R, Magne J, Marais L, Daviet JC. Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. Trials. 2022 Aug 16;23(1):661. doi: 10.1186/s13063-022-06545-w.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 87RI20_0010 (WAKE)

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