The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases) (SPACE-TIC)
Primary Purpose
Post-stroke Patient in Acute or Sub-acute Phase
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamometer
Muscle vibrations
Muscle vibrations
Placebo muscle vibration
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Patient in Acute or Sub-acute Phase
Eligibility Criteria
Inclusion Criteria:
Phase 1:
- Adult patient,
- Medically stable on medical assessment, with no contraindications to stroke rehabilitation management management (no medical problems or acute intercurrent medical events),
- Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the motor skills of the upper limbs,
- 1 ≤ MAS < 4 on elbow flexors,
- Having given oral consent.
Phase 2:
- Adult patient,
- Medically stable on medical evaluation, with no contraindications to stroke rehabilitation (no medical issues or acute intercurrent medical events),
- With a first stroke < 6 weeks previously, confirmed by imaging,
- Altered motor skills in the upper limb (contralateral to the lesion) (Fugl and Meyer score), particularly in the wrist and elbow flexors,
- Requiring inpatient or outpatient hospitalization in a rehabilitation center,
- Having given oral consent.
Exclusion Criteria:
- Phases 1 and 2:
- Significant pain on mobilization of the elbow or wrist (visual analog scale > 5/10),
- Presence of other neurological, muscular or osteoarticular conditions altering the functioning of the upper limb,
- Apparent wound, which may defer inclusion, or very fragile skin,
- Significant cognitive impairment: inability to understand simple instructions or give consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if YES/NO answers are unreliable),
- Not covered by national health insurance,
- Pregnant or breastfeeding,
- Being under guardianship or curatorship.
- Person subject to a measure of legal protection
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Pahse 1
Phase 2: Intervention group
Phase 2: control group
Arm Description
Outcomes
Primary Outcome Measures
Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)
Elbow joint angle (elbow or wrist of the limb contralateral to the brain injury) at the onset of a spastic contraction (maximum intensity of resistance to mobilization) recorded by isokinetic dynamometer on a wheelchair during the initial visit
Phase 2: Scoring wrist flexor muscle spasticity
Scoring of wrist flexor muscle spasticity (especially FCR) by isokinetic dynamometer (angle of onset), at the beginning of the study and at 6 weeks (end of intervention).
Secondary Outcome Measures
Full Information
NCT ID
NCT05315726
First Posted
March 30, 2022
Last Updated
July 31, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT05315726
Brief Title
The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases)
Acronym
SPACE-TIC
Official Title
The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Several studies have recently tested the use of muscle vibration for the rehabilitation of patients after a stroke. When applied in a repeated and focused manner, this vibration appears to promote the recovery of functional capacities through the mechanisms of neuromuscular plasticity. These results are encouraging, showing in particular a significant decrease in spasticity in post-stroke patients in the chronic phase (> 6 months after stroke), on the upper and/or lower limbs. However, very few studies have been done on this type of early intervention. Muscle vibration may therefore be an innovative therapy to complement the care that is currently offered in the acute and subacute phase of post-stroke rehabilitation.
Moreover, brain plasticity after a stroke is particularly high in the 3 months after the accident, but the vast majority of studies having evaluated the impact of vibration in a chronic phase (> 12 months post-stroke). It is likely, however, that the influence of vibration, particularly on brain plasticity, is increased in the acute or subacute phase (first 6 months). To date, the effect of vibration on spinal cord or cortical plasticity has not been quantified in the acute or subacute phase. This is why the second part of this project (phase 2) aims to systematically evaluate and quantify the neuroplastic and functional effects of post-stroke vibration in the early phase.
Phase 1 (duration 2 weeks) - Validation of a method for measuring spasticity (upper limb) with an isokinetic dynamometer 32 patients with ischemic and/or hemorrhagic stroke (> 3 months after stroke)
Phase 2 (duration 6 months): Use of this objective technique to measure the effect of a muscle vibration protocol to limit the onset of spasticity in a population of 100 patients following a stroke, in the acute or subacute phase (< 6 weeks post-stroke) in a randomized trial:
intervention group: usual rehabilitation + muscle vibrations
control group: usual rehabilitation + placebo vibrations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Patient in Acute or Sub-acute Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pahse 1
Arm Type
Experimental
Arm Title
Phase 2: Intervention group
Arm Type
Experimental
Arm Title
Phase 2: control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dynamometer
Intervention Description
Measurement of elbow/wrist spasticity
Intervention Type
Other
Intervention Name(s)
Muscle vibrations
Intervention Description
1 session of 10 minutes
Intervention Type
Other
Intervention Name(s)
Muscle vibrations
Intervention Description
3 times/week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Placebo muscle vibration
Intervention Description
3 times/week for 6 weeks
Primary Outcome Measure Information:
Title
Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury)
Description
Elbow joint angle (elbow or wrist of the limb contralateral to the brain injury) at the onset of a spastic contraction (maximum intensity of resistance to mobilization) recorded by isokinetic dynamometer on a wheelchair during the initial visit
Time Frame
at baseline
Title
Phase 2: Scoring wrist flexor muscle spasticity
Description
Scoring of wrist flexor muscle spasticity (especially FCR) by isokinetic dynamometer (angle of onset), at the beginning of the study and at 6 weeks (end of intervention).
Time Frame
at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phase 1:
Adult patient,
Medically stable on medical assessment, with no contraindications to stroke rehabilitation management management (no medical problems or acute intercurrent medical events),
Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the motor skills of the upper limbs,
1 ≤ MAS < 4 on elbow or wrist flexors,
Having given oral consent.
Phase 2:
Adult patient,
Medically stable on medical evaluation, with no contraindications to stroke rehabilitation (no medical issues or acute intercurrent medical events),
With a first stroke < 6 weeks previously, confirmed by imaging,
Altered motor skills in the upper limb (contralateral to the lesion) (Fugl and Meyer score), particularly in the wrist and elbow flexors,
Requiring inpatient or outpatient hospitalization in a rehabilitation center,
Having given oral consent.
Exclusion Criteria:
Phases 1 and 2:
Significant pain on mobilization of the elbow or wrist (visual analog scale > 5/10),
Presence of other neurological, muscular or osteoarticular conditions altering the functioning of the upper limb,
Apparent wound, which may defer inclusion, or very fragile skin,
Significant cognitive impairment: inability to understand simple instructions or give consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if YES/NO answers are unreliable),
Not covered by national health insurance,
Pregnant or breastfeeding,
Being under guardianship or curatorship.
Person subject to a measure of legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie JULLIAND
Phone
03.80.66.94.82
Email
sophie.julliand@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie JULLIAND
Phone
03.80.66.94.82
Email
sophie.julliand@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases)
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