Walking Ankle isoKinetic Exercise

Stroke Rehabilitation Clinical Trial

— WAKE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800601
• Other study ID #: 87RI20_0010 (WAKE)
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: November 7, 2023

Study information

• Verified date: July 2022
• Source: University Hospital, Limoges
• Contact: Jean Christophe DAVIET, Pr
• Phone: + 33 5 55 05 65 38
• Email: jean-christophe.daviet[@]unilim.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

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)
• 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.

Locations

Country	Name	City	State
France	Reeducation Institute Les Embruns	Bidart
France	University Hospital	Bordeaux
France	University Hospital	Limoges
France	University Institute of Rehabilitation Valmante Sud	Marseille
France	University Hospital	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	10 m walking speed measured at the end of intervention	Week 6
Secondary	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
Secondary	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
Secondary	Walking speed	10m speed: measured at week 26 and week 52	Week 26, Week 52
Secondary	Dorsiflexors strength	Dorsiflexors strength evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and Week 52.	Week 26, Week 52
Secondary	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
Secondary	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