Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504214
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-05
Brief Title:
Tendon Vibrations Effect on Upper Limb Motor Recovery After Recent Stroke
Sponsor:
Centre Borelli UMR 9010
Organization:
Centre Borelli UMR 9010
Study Overview
Official Title:
A Pilot Study of Proprioception Stimulation by Repeated Multi-site Tendon Vibrations on Upper Limb Motor Skills Recovery After Recent Stroke
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIBRAMOT
Brief Summary:
Stroke is the leading cause of severe acquired disabilities in adults It can affect sensory and motor functions which are closely entangled Among them upper limb function is often strongly impaired In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion
Stimulation by tendinous vibrations applied to the musculotendinous endings has been already proposed in post stroke rehabilitation but only at late stages Thus the aim of our study is to observe the effects of repeated tendon vibrations applied in the early post stroke phase the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery motor control and activities
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion
Stimulation by tendinous vibrations applied to the musculotendinous endings has been already proposed in post stroke rehabilitation but only at late stages Thus the aim of our study is to observe the effects of repeated tendon vibrations applied in the early post stroke phase the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery motor control and activities
Detailed Description:
Stroke is the leading cause of severe acquired disabilities in adults It can affect sensory and motor functions which are closely entangled Among them upper limb function is often strongly impaired In this study the investigators are interested in the eventuality to improve motor recovery by the mean of stimulating the proprioception
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion
Stimulation by tendinous vibrations applied to the musculotendinous endings has been already proposed in post stroke rehabilitation but only at late stages
Thus the aim of our study is to observe the effects of repeated tendon vibrations applied in the early post stroke phase the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery motor control and activities
Patients 30 patients recruited after a first ever stroke whatever the cause and the site age 18 stroke delay 60 days the maximum duration of participation for each patient is 3 months
Protocol
This rehabilitation protocol will be added to the usual rehabilitation program during inpatient rehabilitation
Participants are randomized into two groups experimental group and placebo group
The experimental group benefits from upper limb tendon vibration sessions produced by small electromechanical vibrators on the elbow and the wrist Frequency of the vibration is 80 Hz two 15-minutes sessions per day scheduled for 10 days over a period of two weeks 2 x 5 days During the sessions the participant wearing opaque glasses in a seating position is asked to move if possible hisher arm in the opposite direction of the perceived movement
The placebo group receives apparently the same treatment but with sham vibration
Assessment
Motor recovery will be assessed
At the brain level by the efficiency of the primary motor pathway measured by Motor Evoked Potentials recorded at the contralateral hand main outcome criteria after 30 days from inclusion
At the limb level by the motor control effectiveness measured by the Fugl Meyer scale the Tardieu scale the Action Research Arm Test ARAT the Box and Blocks Test BBT and the range of upper limb exploration with the ArmeoSpring Hocoma brand
The secondary objectives are
To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging
To test the feasibility of such a rehabilitation protocol in a Physical Rehabilitation Medicine department
Four consultations are planned
D0 day 0 before starting stimulation Motor skills assessments Motor Evoked Potentials MEP and Magnetic Resonance Imaging MRI
D15 day 15 as soon as stimulation ends Motor skills assessments D30 day 30 Motor skills assessments and Motor Evoked Potentials MEP D90 day 90 Motor skills assessments Motor Evoked Potentials MEP and Magnetic Resonance Imaging MRI
Proprioception can be stimulated by tendinous vibrations in order to act on the neuromuscular system through the vibratory tonic reflex and by movement illusion
Stimulation by tendinous vibrations applied to the musculotendinous endings has been already proposed in post stroke rehabilitation but only at late stages
Thus the aim of our study is to observe the effects of repeated tendon vibrations applied in the early post stroke phase the effect being measured on the excitability of the motor cortex by the Motor Evoked Potentials and on the motor recovery motor control and activities
Patients 30 patients recruited after a first ever stroke whatever the cause and the site age 18 stroke delay 60 days the maximum duration of participation for each patient is 3 months
Protocol
This rehabilitation protocol will be added to the usual rehabilitation program during inpatient rehabilitation
Participants are randomized into two groups experimental group and placebo group
The experimental group benefits from upper limb tendon vibration sessions produced by small electromechanical vibrators on the elbow and the wrist Frequency of the vibration is 80 Hz two 15-minutes sessions per day scheduled for 10 days over a period of two weeks 2 x 5 days During the sessions the participant wearing opaque glasses in a seating position is asked to move if possible hisher arm in the opposite direction of the perceived movement
The placebo group receives apparently the same treatment but with sham vibration
Assessment
Motor recovery will be assessed
At the brain level by the efficiency of the primary motor pathway measured by Motor Evoked Potentials recorded at the contralateral hand main outcome criteria after 30 days from inclusion
At the limb level by the motor control effectiveness measured by the Fugl Meyer scale the Tardieu scale the Action Research Arm Test ARAT the Box and Blocks Test BBT and the range of upper limb exploration with the ArmeoSpring Hocoma brand
The secondary objectives are
To assess any impact on nerve fibers density on the main motor pathway by Magnetic Resonance Imaging
To test the feasibility of such a rehabilitation protocol in a Physical Rehabilitation Medicine department
Four consultations are planned
D0 day 0 before starting stimulation Motor skills assessments Motor Evoked Potentials MEP and Magnetic Resonance Imaging MRI
D15 day 15 as soon as stimulation ends Motor skills assessments D30 day 30 Motor skills assessments and Motor Evoked Potentials MEP D90 day 90 Motor skills assessments Motor Evoked Potentials MEP and Magnetic Resonance Imaging MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None