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临床试验/NCT07629674
NCT07629674招募中不适用

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)

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年7月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

盲法说明

sham video therapy

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 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.

排除标准

  • - Severe hemispatial neglect.
  • Severe spasticity impairing proper positioning (Modified Ashworth Scale > 3).
  • Severe general disabling medical conditions.
  • Associated cerebellar syndrome.
  • Major comprehension disorders, psychiatric illness, or cognitive impairments that could interfere with study participation.
  • Participants under full legal guardianship (tutorship).
  • Pregnant or breastfeeding women.

研究组 & 干预措施

Sequence 1

Experimental

1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.

干预措施: Active Videotherapy (Device)

Sequence 1

Experimental

1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.

干预措施: Sham videotherapy (Device)

Sequence 2

Experimental

2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy.

干预措施: Active Videotherapy (Device)

Sequence 2

Experimental

2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy.

干预措施: Sham videotherapy (Device)

Sequence 3

Experimental

3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) ,

干预措施: Active Videotherapy (Device)

Sequence 3

Experimental

3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) ,

干预措施: Sham videotherapy (Device)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arnauld GARCIN

Dr

Centre Hospitalier Universitaire de Saint Etienne

研究点 (1)

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