Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

Objective: The aim of this study is to compare the efficiency of vision-obscured versus vision-retained treadmill gait training in subacute post-stroke patients.

Methodology: Thirty-six patients with stroke (ischemic or hemorrhagic) less than six months old will be included and randomized into two parallel groups. The experimental group will undergo treadmill gait training using an opaque mask, combined with body weight reduction (Lite Gait® harness). The control group will follow the same walking protocol, but with their eyes open. Each session will last 20 minutes, integrated into one hour of rehabilitation, at a rate of three sessions per week for six weeks. Assessment will include single- and double-task walking speed, balance parameters and proprioception.

Expected results: The hypothesis is that visual deprivation will stimulate the proprioceptive and vestibular systems to a greater extent, resulting in benefits for postural balance, walking and proprioception. The main hypothesis will be the improvement in the difference between single-task and double-task walking speed. Analyses will be conducted on an intention-to-treat basis, using statistical tests adapted to the nature of the variables.

Conclusion: This study could highlight the value of temporary visual suppression as a therapeutic lever in stroke rehabilitation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older,

With a confirmed diagnosis of ischemic or hemorrhagic stroke in sub-acute phase (stroke less than 6 months old),

With NIHSS scores between 1 and 15 and MoCA scores between 18 and 30

With a physiotherapy prescription for post Stroke rehabilitation

Disqualifiers

Patients weighing over 200 kg (maximum weight permitted for use of the Lite Gait ®),

Best corrected visual acuity below 5/10 on patient examination

Homonymous lateral hemianopia, quadranopia.

Inability to physically participate in intensive rehabilitation due to severe, unstabilized and comorbidities (heart, lung, kidney disease or diabetes), severe psychiatric disorders cancer active or under treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hiding the eyes

    Procedure/Surgery

    Patients will participate in walking rehabilitation sessions on a treadmill supported by a Lite Gait® harness. All treadmill sessions are consistent with regular rehabilitation sessions. A typical treadmill walking session will take place 3 times a week for 6 weeks, lasting 20 minutes. During the first minute, the speed of the treadmill is gradually increased until a comfortable speed is reached. From then on, the mask will be placed over the patient's eyes for 18 minutes at a constant, i.e. comfortable, speed. The last minute will be devoted to gradually decreasing the treadmill speed until it stops, and will also be performed without the mask.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Hidden EyesExperimental treatment 1 intervention
Group B: Open EyesNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Dual-task walking speed assessment

Speed (m/s) The dual-task walking speed assessment measures how well a person walks while simultaneously performing a cognitive or motor task. It helps identify changes in gait speed and stability when attention is divided, revealing potential fall risk or cognitive-motor interference.

Time frame
6 weeks after subacute stroke

Secondary outcomes

1

Gait Speed assessment

Gait speed (m/s)

Time frame
3 to 6 monts after subacute stroke
2

Average step duration evaluation

Average step duration (s)

Time frame
3 to 6 monts after subacute stroke
3

Gait symmetry evaluation

Gait symmetry (%)

Time frame
3 to 6 monts after subacute stroke
4

Cycle duration variability evaluation

Cycle duration variability (%)

Time frame
3 to 6 monts after subacute stroke

Other outcomes

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