Walking Ankle isoKinetic Exercise (WAKE)
Primary Purpose
Stroke Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rehabilitation program 1
Rehabilitation program 2
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Rehabilitation
Eligibility Criteria
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
Sites / Locations
- Reeducation Institute Les EmbrunsRecruiting
- University HospitalRecruiting
- University HospitalRecruiting
- University Institute of Rehabilitation Valmante SudRecruiting
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Walking speed
10 m walking speed measured at the end of intervention
Secondary Outcome Measures
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).
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.
Walking speed
10m speed: measured at week 26 and week 52
Dorsiflexors strength
Dorsiflexors strength evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and 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.
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)
Full Information
NCT ID
NCT04800601
First Posted
March 8, 2021
Last Updated
July 22, 2022
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT04800601
Brief Title
Walking Ankle isoKinetic Exercise
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
November 7, 2023 (Anticipated)
Study Completion Date
November 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Rehabilitation program 1
Intervention Description
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
Intervention Name(s)
Rehabilitation program 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking speed
Description
10 m walking speed measured at the end of intervention
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Social participation
Description
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).
Time Frame
Week 26, Week 52
Title
Walking spatio-temporal parameters
Description
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.
Time Frame
Week 0, Week 6, Week 26, Week 52
Title
Walking speed
Description
10m speed: measured at week 26 and week 52
Time Frame
Week 26, Week 52
Title
Dorsiflexors strength
Description
Dorsiflexors strength evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and Week 52.
Time Frame
Week 26, Week 52
Title
Use of technical aids to walk and the number of fall
Description
The use of technical aids to walk and the number of falls will be listed in Week 52.
Time Frame
Week 52
Title
Correlations between walking speed /dorsiflexor muscles strength
Description
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)
Time Frame
Week 0, Week 6, Week 26, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Christophe DAVIET, Pr
Phone
+ 33 5 55 05 65 38
Email
jean-christophe.daviet@unilim.fr
Facility Information:
Facility Name
Reeducation Institute Les Embruns
City
Bidart
ZIP/Postal Code
64210
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François MULLER, Dr
Phone
+ 33 5 59 51 32 49
Email
f.muller@lesembruns.com
Facility Name
University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffroy MOUCHEBOEUF, Dr
Phone
+ 33 5 56 79 55 46
Email
geoffroy.moucheboeuf@chu-bordeaux.fr
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe DAVIET, Pr
Phone
+ 33 5 55 05 65 38
Email
jean-christophe.daviet@unilim.fr
Facility Name
University Institute of Rehabilitation Valmante Sud
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BENSOUSSAN, Pr
Phone
+ 33 4 88 22 86 99
Email
Laurent.bensoussan@ap-hm.fr
Facility Name
University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne JOSSART, Dr
Phone
+ 33 5 49 44 44 26
Email
Anne.jossart@chu-poitiers.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35974379
Citation
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.
Results Reference
derived
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