Walking Ankle isoKinetic Exercise

NCT ID: NCT04800601

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2026-05-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Rehabilitation program 1

Intervention Type OTHER

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)

Control group

Group Type ACTIVE_COMPARATOR

Rehabilitation program 2

Intervention Type OTHER

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.

Interventions

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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)

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe DAVIET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Reeducation Institute Les Embruns

Bidart, , France

Site Status TERMINATED

University Hospital

Bordeaux, , France

Site Status ACTIVE_NOT_RECRUITING

DUBOIS Hospital

Brive-la-Gaillarde, , France

Site Status NOT_YET_RECRUITING

University Hospital

Limoges, , France

Site Status RECRUITING

University Institute of Rehabilitation Valmante Sud

Marseille, , France

Site Status RECRUITING

Functional rehabilitation center

Noth, , France

Site Status NOT_YET_RECRUITING

University Hospital

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Christophe DAVIET, Pr

Role: CONTACT

+ 33 5 55 05 65 38

Facility Contacts

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Sonia JEDDI

Role: primary

Jean-Christophe DAVIET, Pr

Role: primary

+ 33 5 55 05 65 38

Laurent BENSOUSSAN, Pr

Role: primary

+ 33 4 88 22 86 99

Alfredo MUSUMECI

Role: primary

Anne JOSSART, Dr

Role: primary

+ 33 5 49 44 44 26

References

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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.

Reference Type DERIVED
PMID: 35974379 (View on PubMed)

Other Identifiers

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87RI20_0010 (WAKE)

Identifier Type: -

Identifier Source: org_study_id

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