Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- First or recurrent hemispheric ischemic or hemorrhagic stroke in the subacute or chronic phase (from 1 month to 1 year post-stroke).

Currently receiving rehabilitation care in a Physical Medicine and Rehabilitation (PM&R) department

Able to walk 3 meters back and forth, with or without an assistive device.

Provided informed consent, signed jointly with the investigator.

Disqualifiers

- Severe hemispatial neglect.

Severe spasticity impairing proper positioning (Modified Ashworth Scale > 3).

Severe general disabling medical conditions.

Associated cerebellar syndrome.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Active Videotherapy

    Device

    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).

  • Sham videotherapy

    Device

    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.

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: Sequence 1Experimental treatment 2 interventions
Group B: Sequence 2Experimental treatment 2 interventions
Group C: Sequence 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

1. Timed Up and Go Test (TUG)

Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)

Time frame
5-week

Secondary outcomes

1

2. 2-Minute Walk Test (2MWT)

Walking endurance assessed by the distance walked in 2 minutes (in meters).

Time frame
Weeks 1, 2, 3, 8, 13, 17, and 21
2

3. Fugl-Meyer Assessment - Lower Limb Section

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
3

4. Muscle Strength - Foot Dorsiflexors and extensors

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
4

5. Muscle Tone - Modified Ashworth Scale (MAS)

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

Other outcomes

Sponsors and contacts

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