NCT04800601

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

March 8, 2021

Last Update Submit

May 28, 2024

Conditions

Stroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Walking speed

    10 m walking speed measured at the end of intervention

    Week 6

Secondary Outcomes (6)

  • Social participation

    Week 26, Week 52

  • Walking spatio-temporal parameters

    Week 0, Week 6, Week 26, Week 52

  • Walking speed

    Week 26, Week 52

  • Dorsiflexors strength

    Week 26, Week 52

  • Use of technical aids to walk and the number of fall

    Week 52

  • +1 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL
Other: Rehabilitation program 1

Control group

ACTIVE COMPARATOR
Other: Rehabilitation program 2

Interventions

Rehabilitation program 1OTHER

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)

Experimental group
Rehabilitation program 2OTHER

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Reeducation Institute Les Embruns

Bidart, 64210, France

TERMINATED

University Hospital

Bordeaux, 33000, France

ACTIVE NOT RECRUITING

DUBOIS Hospital

Brive-la-Gaillarde, 19312, France

NOT YET RECRUITING

University Hospital

Limoges, 87042, France

RECRUITING

University Institute of Rehabilitation Valmante Sud

Marseille, 13009, France

RECRUITING

Functional rehabilitation center

Noth, 23300, France

NOT YET RECRUITING

University Hospital

Poitiers, 86021, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35974379DERIVED

Study Officials

  • Jean-Christophe DAVIET

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Christophe DAVIET, Pr

CONTACT

+ 33 5 55 05 65 38jean-christophe.daviet@unilim.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 16, 2021

Study Start

May 20, 2021

Primary Completion

May 20, 2026

Study Completion

May 20, 2026

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)