Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
2022年1月6日 更新者：Dorothy Barthélemy、Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.
調査の概要
詳細な説明
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- Assessment 1 week after training
- Assessment 1 month after training (follow-up)
Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:
- Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
- Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.
After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).
研究の種類
介入
入学 (予想される)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dorothy Barthélemy, PhD, PT
- 電話番号：514-343-7712
- メール：dorothy.barthelemy@umontreal.ca
研究場所
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Quebec
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Montréal、Quebec、カナダ
- 募集
- Neuromobility lab
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コンタクト：
- Dorothy Barthélemy, PhD, PT
- 電話番号：514-343-7712
- メール：dorothy.barthelemy@umontreal.ca
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
FOR PARTICIPANTS WITH SPINAL CORD INJURY
Inclusion Criteria:
- Have an incomplete lesion of spinal cord
- Level of spinal cord lesion between C5 and T12
- At least, 6 months post-injury
- Be considered as AIS C or D
- Be able to stand without support for 15 seconds
- Be able to provide informed consent in English or in French
Exclusion Criteria:
- To have cognitive deficits
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
FOR CONTROL PARTICIPANTS
Exclusion Criteria:
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Combined explosive strength and specific balance training group
This group will be formed with participants with incomplete spinal cord injury.
This group will perform 4 weeks of combined explosive strength and specific balance training.
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Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations. Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements. Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:
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介入なし：Spinal cord injury control group
This group will be formed with participants with incomplete spinal cord injury.
They will perform all the evaluation before and after a 4-week period of rest (no training).
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介入なし：Healthy control group
Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.
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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 |
|---|---|---|
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Change in muscles EMG responses following balance perturbation
時間枠：Pre-intervention, immediately after and one-month after intervention
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Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
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Pre-intervention, immediately after and one-month after intervention
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Change in center of pressure displacement following balance perturbation using a force platform
時間枠：Pre-intervention, immediately after and one-month after intervention
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Excursion of centre of pressure will be analyzed following forward and backward perturbation.
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Pre-intervention, immediately after and one-month after intervention
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Change in ankle muscle strength using force transducer
時間枠：Pre-intervention, immediately after and one-month after intervention
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Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
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Pre-intervention, immediately after and one-month after intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
時間枠：Pre-intervention, immediately after and one-month after intervention
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A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
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Pre-intervention, immediately after and one-month after intervention
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Change in the influence of peripheral afferents on cortical output using short-afference inhibition
時間枠：Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just after a peripheral electrical stimulation of tibial nerve to evaluate the peripheral afferents on cortical output.
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Pre-intervention, immediately after and one-month after intervention
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Change in the modulation of the H reflex by the corticospinal tract
時間枠：Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just before a tibial nerve stimulation to evaluate the modulation of the H reflex by the corticospinal tract.
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Pre-intervention, immediately after and one-month after intervention
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Change in EMG responses following vestibular stimulations during quiet standing
時間枠：Pre-intervention, immediately after and one-month after intervention
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Galvanic vestibular stimulation will be triggered during quiet standing.
EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
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Pre-intervention, immediately after and one-month after intervention
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Change in the excursion of the center of pressure following vestibular stimulations
時間枠：Pre-intervention, immediately after and one-month after intervention
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Galvanic vestibular stimulation will be triggered during quiet standing.
The displacement of the center of pressure will be analyzed using a force platform.
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Pre-intervention, immediately after and one-month after intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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MOntreal Cognitive Assessment (MoCA) score
時間枠：Before enrollment
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The maximal score is 30 and minimal score 0.
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Before enrollment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年7月9日
一次修了 (予想される)
2022年12月1日
研究の完了 (予想される)
2022年12月1日
試験登録日
最初に提出
2021年9月1日
QC基準を満たした最初の提出物
2022年1月6日
最初の投稿 (実際)
2022年1月20日
学習記録の更新
投稿された最後の更新 (実際)
2022年1月20日
QC基準を満たした最後の更新が送信されました
2022年1月6日
最終確認日
2022年1月1日
詳しくは
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。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル