Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke (SI-VI-MI)
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)
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.
調査の概要
詳細な説明
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
.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Etienne OJARDIAS, Dr
- 電話番号：33 0477127018
- メール：Etienne.Ojardias@chu-st-etienne.fr
研究場所
-
-
-
Saint-Etienne、フランス、42100
- 募集
- Service de Médecine Physique et réadaptation
-
副調査官：
- Hugo BESSAGUET, MD
-
副調査官：
- Julia TOULY, MD
-
コンタクト：
- Diana RIMAUD, PhD
- 電話番号：33 04 77 12 04 67
- メール：Diana.Rimaud@chu-st-etienne.fr
-
副調査官：
- Pascal GIRAUX, MD, PhD
-
主任研究者：
- Etienne OJARDIAS, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- - 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sequence 1
1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.
|
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.
|
|
実験的：Sequence 2
2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy.
|
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.
|
|
実験的：Sequence 3
3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) ,
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1. Timed Up and Go Test (TUG)
時間枠：5-week
|
Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
|
5-week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
2. 2-Minute Walk Test (2MWT)
時間枠：Weeks 1, 2, 3, 8, 13, 17, and 21
|
Walking endurance assessed by the distance walked in 2 minutes (in meters).
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
|
3. Fugl-Meyer Assessment - Lower Limb Section
時間枠：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)
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
|
4. Muscle Strength - Foot Dorsiflexors and extensors
時間枠：Weeks 1, 2, 3, 8, 13, 17, and 21
|
Muscle strength of the foot dorsiflexors and extensors, measured in Newtons using a handheld dynamometer
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
|
5. Muscle Tone - Modified Ashworth Scale (MAS)
時間枠：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).
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
|
6. Muscle Tone - Modified Tardieu Scale
時間枠：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).
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
|
7. Postural Balance - PASS (Postural Assessment Scale for Stroke Patients)
時間枠：Weeks 1, 2, 3, 8, 13, 17, and 21
|
Balance ability assessed using the PASS scale (score 0-36).
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
|
8. Quality of Life - Stroke Specific Quality of Life Scale (SS-QOL)
時間枠：Weeks 1, 2, 3, 8, 13, 17, and 21
|
Quality of life assessed with the SS-QOL scale (score range: 49-245).
|
Weeks 1, 2, 3, 8, 13, 17, and 21
|
協力者と研究者
捜査官
- 主任研究者：Etienne OJARDIAS, Dr、Centre Hospitalier Universitaire de Saint Etienne
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 25CH169
- 2025-A02102-47 (その他の識別子：ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。