An interventional study of TVS rehabilitation sessions in Acute Stroke and Upper Limb Motor Deficit, sponsored by Centre Hospitalier Régional d'Orléans. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Treatment
Strokes often induce a motor deficit. The resulting immobilization is in itself an aggravation factor since it worsens the motor deficit induced by the stroke itself.
Amongst the different sensory stimulations, the use of tendon vibratory stimulations (TVS) that activate proprioceptive pathways (muscle spindle fibers) is gaining increasing interest in the rehabilitation world.
Tendon vibratory stimulation (TVS) can be used on patients with little to no voluntary motor functions. Therefore, it seems particularly suited to significant upper limb deficits, and especially as early as possible after a stroke occurs when motor skills are severely affected.
Various studies have shown the interest of using vibratory stimulations in the management of post-stroke motor disorders. The majority were conducted in the chronic stroke stage. Only one small scale study has been conducted on the acute stroke stage.
For patients with upper limb function deficit in acute stroke stage, is studied the effect of added tendon vibratory stimulation (TVS) to the usual rehabilitation sessions.
The vibratory stimulation equipment is Vibramoov physio (Techno Concept) 54 patients will be randomized in two groups, stratified on SAFE score and age:
Experimental group: Tendon vibratory stimulation (TVS) technique (30min) added before the usual rehabilitation session For the TVS technique: two stimulators will be placed on the distal part of the forearm: the first on the anterior side the second on the posterior side. The patient will receive 3 sets of 10 min stimulation spaced 1min apart. The stimulation frequency is 100 Hz, the amplitude is 2 mm.
10 rehabilitation sessions will occur within a period between 10 and 25 days after inclusion.
3 different time slots are defined for evaluations: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions T3: After 10 rehabilitation session or when the patient leaves (if before 10 sessions with a minimum of 8)
Will be evaluated in the two groups at T1, T2 and T3:
7,476 studies on the registry are indexed under Stroke; 2,024 are open to participants now.
This study's planned enrollment of 54 is close to the median of 50 across 5,506 interventional studies indexed under Stroke.
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Patients randomized in the experimental group will have Tendon vibratory stimulation (TVS) technique (30min) added before their usual rehabilitation session (30min).
Procedure: TVS rehabilitation sessions
Patients randomized in the control group will have the usual rehabilitation session (30min).
Patients randomized in the experimental group will have Tendon vibratory stimulation (TVS) technique (30min) added before their usual rehabilitation session Two stimulators will be placed on the distal part of the forearm: the first on the anterior side the second on the posterior side. The patient will receive 3 sets of 10 min stimulation spaced 1min apart. The stimulation frequency is 100 Hz, the amplitude is 2 mm.
Study whether adding tendon vibratory stimulation (TVS) to the usual rehabilitation sessions on the after upper limb after a stroke improves the recovery of the limb's motor strength.
Fugl Meyer Assesment (FMA) of the affected limb after 5 rehabilitation session (T2) with or without the TVS. FMA score ranges from 0 to 66, with 0 representing the most severe deficit and 66 representing normal motor function.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days)
Study the effect of adding TVS rehabilitation on the motor strength of the affected upper limb over time.
Motor strength of the affected upper limb scored by Shoulder Abduction and Finger Extension (SAFE) Score. The SAFE score is calculated by summing the MRC grades for shoulder abduction and finger extension. The total score ranges from 0 to 10, where 0 represents no voluntary muscle activity in shoulder abduction and finger extension and 10 represents normal strength in both movement.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study the effect of adding TVS rehabilitation on wrist motor strength over time.
Motor strength of the wrist (on the affected upper limb) is evaluated by subsection n°6 of the Fugl Meyer Assesment (FMA). Score ranges from 0 (severe impairment) to 6 (normal coordination and speed)
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study the effect of adding TVS rehabilitation on finger grip strength over time.
Grip strength evaluated with a Jamar dynamometer (the value retained being the average of 3 tries).
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding TVS rehabilitation improves the conscious deep sensitivity of the affected upper limb over time
Conscious deep sensitivity of the affected upper limb is evaluated by Thumb Localization Test (TLT). TLT ranges from 0 to 3, where 0 indicates normal thumb localization and 3 indicates severe proprioceptive impairment with inability to accurately locate the thumb.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding STV therapy reduces spasticity in the affected upper limb over time.
Spasticity is evaluated by modified Ashworth scale. This scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Study whether adding STV therapy reduces pain in the affected upper limb over time
Pain in the affected upper limb is evaluated by Visual Analogue Scale (VAS). The VAS ranges from 0 to 10. 0 represents the worst pain and 10 represents no pain.
Time frame: T1: Right before the first rehabilitation session T2: After 5 rehabilitation sessions (up to 7 days) T3: After 10 rehabilitation session (up to 25 days) or when the patient leaves (if before 10 sessions with a minimum of 8)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 2,877 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 25 months is close to that.
Counting every sponsor, half of 3,006 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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