NCT Number: NCT07629674
This pilot study evaluates video therapy for lower limb motor recovery after stroke, an approach remains insufficiently documented.
This single-center pilot study uses a Single-Case Experimental Design (SCED) to evaluate the effects of intensive video therapy combined with conventional rehabilitation in patients with subacute or chronic post-stroke hemiparesis. Twelve participants will be included and allocated to different baseline durations according to a multiple-baseline SCED design.
The primary outcome is functional mobility, assessed using the Timed Up and Go (TUG) test, measured repeatedly throughout baseline, intervention, and follow-up phases.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Saint-Etienne, 42100, France
Location status: Recruiting
Diana RIMAUD, PhD
CONTACT
04 77 12 04 67 ext. 33
Etienne OJARDIAS, MD
PRINCIPAL_INVESTIGATOR
Hugo BESSAGUET, MD
SUB_INVESTIGATOR
Julia TOULY, MD
SUB_INVESTIGATOR
Pascal GIRAUX, MD, PhD
SUB_INVESTIGATOR
Stroke frequently results in persistent lower limb motor impairment affecting gait and functional mobility (1-2). While video-based therapies have shown proof of concept for upper limb rehabilitation after stroke, their effectiveness for lower limb motor recovery remains insufficiently documented (3-5).
This study is a single-center pilot trial using a Single-Case Experimental Design (SCED) with multiple baseline durations, chosen to account for the high interindividual variability observed in subacute and chronic post-stroke patients undergoing rehabilitation (6). This design allows each participant to serve as their own control through repeated measurements over time (6).
Participants are included between 1 month and 1 year post-stroke while receiving inpatient or outpatient rehabilitation in a Physical Medicine and Rehabilitation department. All participants initially undergo a control phase combining standardized rehabilitation with sham video therapy (placebo condition). The duration of this baseline phase is randomized (1, 2, or 3 weeks) across participants.
The experimental phase consists of 5 weeks of intensive video therapy added to usual care, with five sessions per week. A post-intervention sham phase is followed by a follow-up period lasting up to 21 weeks post-intervention, with repeated assessments conducted at weeks 13, 17, and 21 to evaluate maintenance of treatment effects.
The primary objective is to evaluate changes in functional mobility, assessed using repeated measurements of the Timed Up and Go test. Secondary objectives include evaluation of gait endurance, motor impairment, muscle tone, balance, and quality of life
.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During active videotherapy sessions, the image inversion program is activated, superimposing movements of the non-paretic limb onto the paretic limb, which is hidden behind the screen. Participants are instructed to imagine and attempt to reproduce the observed movements using their paretic limb. Each participant completes 25 sessions over 5 weeks (5 sessions per week).
During sham videotherapy sessions, participants are seated facing the IVS4 screen without activation of the image inversion program. Participants perform lower limb movements while directly viewing their paretic limb in real time on the screen, corresponding to an action observation condition without visual illusion.
Time frame: 5-week
Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Walking endurance assessed by the distance walked in 2 minutes (in meters).
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Motor function of the hemiplegic lower limb, assessed with the Fugl-Meyer scale (score from 0 to 34)
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Muscle strength of the foot dorsiflexors and extensors, measured in Newtons using a handheld dynamometer
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Spasticity assessment of dorsiflexors and extensors of the foot using the Modified Ashworth Scale (score 0-5).
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Spasticity assessment of dorsiflexors and extensors of the foot using the Modified Tardieu Scale (score 0-5).
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Balance ability assessed using the PASS scale (score 0-36).
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
Quality of life assessed with the SS-QOL scale (score range: 49-245).
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Saint Etienne
Other
Use of Intensive Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke (SIVIMI). A Single-Center Pilot Study Using a Single-Case Experimental Design (SCED)
Acronym: SI-VI-MI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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