Combined Cognitive and Gait Training (CogGait)
調査の概要
詳細な説明
Aim 1, Hypothesis Ia: Comparison of combined motor and cognitive training vs motor training alone. For Aim 1, Hypothesis Ia, this will be a randomized, controlled study. For the two groups, 38 subjects will be enrolled and randomized to either: A) Motor + Cognitive Training; or B) Motor Training alone. Subjects will first be stratified according to coordination and gait deficit severity, as described below. After stratification, the subject will be randomized to one of the two intervention groups for Hypothesis Ia. All the subjects will receive treatment 5 times/week, 3hrs/session, for 12 weeks or for a total of 60 treatment sessions. Group A will receive combined motor and cognitive training; Table 2 (below) shows the graduated approach to providing combined gait and cognitive training. Data collection will be at weeks 1, 6, 12, and 24 (i.e., before, mid-treatment and after treatment, and then 3 months after the end of the treatment protocol. Comparison will be made between the two groups to determine whether there was any additive effectiveness of the cognitive training.
Aim 2, Hypotheses IIa-d: Pre/post-treatment comparisons within Group A, receiving combined motor and cognitive training. For Aim 2, Hypotheses IIa-d, this will be a single cohort pre/post-treatment comparison within Group A receiving combined motor and cognitive training.
Aim 3, Hypotheses IIIa-d: Pre/post-treatment comparisons within Group B, receiving motor training alone. For Aim 3, Hypotheses IIIa-d, this will be a single cohort pre/post-treatment comparison within Group B, receiving motor training alone.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Gainesville、Florida、アメリカ、32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Stroke Survivor inclusion/exclusion criteria Inclusion Criteria
- Cognition sufficiently intact to give valid informed consent to participate. *
- Sufficient endurance to participate in rehabilitation sessions.
- Ability to follow 2 stage commands.
- Medically Stable
- Age > 21 years.
- Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal plane, in a normal manner so the foot clears the floor; inability to control normal knee angle during single limb weight bearing during stance phase.
- At least 6 months post stroke.
Able-bodied Inclusion criteria
- Criteria to be included is that they should be healthy with no history of a neurological disease or orthopedic impairment.**
- Not Pregnant.
- No Claustrophobia (only for the sub-sample asked to undergo fMRI.)
- No counterindications to MR scanning including, pregnancy, weight inappropriate for height, ferrous objects within the body (only for the sub-sample asked to undergo fMRI.)
Exclusion Criteria:
Exclusion Criteria
- Acute or progressive cardiac, vascular, renal, respiratory, neurological disorders or malignancy.
- Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
- Lower motor neuron damage or radiculopathy.
- Orthopedic impairment. **
- More than one stroke.
- Cerebellar dysfunction.
- Fugl-Meyer lower limb motor sub-score greater than 32.
- No simultaneous gait rehabilitation participation.
- Pregnant.
- Claustrophobia (only for the sub-sample asked to undergo fMRI.)
- Criteria specific to MR scanning, including pregnancy, weight inappropriate for height, ferrous objects within the body (only for the sub-sample asked to undergo fMRI.)
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：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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アクティブコンパレータ：Gait plus cognitive training
Rehabilitation of walking/gait, combined with rehabilitation of cognitive function
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Treatment will include coordination exercises and over ground gait training for impaired muscle groups and related gait deficits.
The therapy will be provided by a clinical physical therapist specializing in rehabilitation for stroke patients, according to established, conventional guidelines.
The protocol was used in the investigators' prior studies, and is designed to restore voluntary control of ankle dorsiflexion during swing phase; hip flexion during swing phase, knee flexion at toe-off, knee flexion during swing phase; knee extension before heel strike; knee control during stance phase; pelvic control during stance phase; and whole body balance control during weight shifting.
Newly-learned coordinated movements will be integrated into practice of coordinated gait components.
Cognitive rehabilitation will begin with the least difficult aspects of attention control, and progress to the more difficult.
Home practice and generalization exercises will be assigned.
Cognitive training is designed to enhance attention, intention, executive function, decision making and reaction time.
Commercially available computer software will be used, as well as custom cognitive training.
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アクティブコンパレータ：Gait plus arm training
Rehabilitation of walking/gait, combined with rehabilitation of arm function
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Treatment will include coordination exercises and over ground gait training for impaired muscle groups and related gait deficits.
The therapy will be provided by a clinical physical therapist specializing in rehabilitation for stroke patients, according to established, conventional guidelines.
The protocol was used in the investigators' prior studies, and is designed to restore voluntary control of ankle dorsiflexion during swing phase; hip flexion during swing phase, knee flexion at toe-off, knee flexion during swing phase; knee extension before heel strike; knee control during stance phase; pelvic control during stance phase; and whole body balance control during weight shifting.
Newly-learned coordinated movements will be integrated into practice of coordinated gait components.
Cognitive rehabilitation will begin with the least difficult aspects of attention control, and progress to the more difficult.
Home practice and generalization exercises will be assigned.
Treatment will include coordination exercises for reaching and grasping.
Activities will include movement of shoulder, elbow, wrist and fingers.
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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 the Gait Assessment and Intervention (G.A.I.T.) Score
時間枠：pre-training (0 weeks), post training (about 12 weeks)
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Coordination of walking, scored using the investigators' novel G.A.I.T. measure.
This measure evaluated limb and joint movements while participants walk overground at preferred speed.
Range of scale: 0 (normal) to 64 (extremely discoordinated gait).
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pre-training (0 weeks), post training (about 12 weeks)
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協力者と研究者
捜査官
- 主任研究者：Janis J. Daly, PhD MS、North Florida/South Georgia Veterans Health System, Gainesville, FL
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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