Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to investigate the efficacy and safety of digital interactive technology with artificial intelligence and biofeedback Smart glove "SensoRehab" for restoration of in-hand manipulation in patients with ischemic stroke in the early and late recovery periods.
The study is an open-label observational trial. Brain stroke (BS) is one of the main causes of upper limb (UL) dysfunction and limitations of daily human activity.The fine use of the hand imparement is often combined with speech, cognitive and emotional disturbances, which is due to the anatomical proximity and close functional relationships of the corresponding areas in the cerebral cortex.
The objective of the present study will be to evaluate the effectiveness and safety of the digital interactive technology (DIT) with artificial intelligence and biofeedback Smart glove "SensoRehab" (SGSR) for restoration of in-hand manipulation in patients with ischemic stroke in the early and late recovery period.The SGSR technique involves neurosensory training and retraining to improve the fine use of the hand and arm, and the patient's cognitive and emotional state.
30 patients will be include to the study. After a basic assessment of hand motor function and game training, each patient undergoes sessions on the SGSR system. The program for BS patients includes 10 sessions with the SGSR (15-30 minutes once a day for the affected hand, 2 weeks).
The clinical outcomes will be obtained at the completion of treatment (2 weeks) and at 1 month after ompletion of the course of rehabilitation. The statistical analysis will follow the intention-to-treat principles.
The outcomes of interest are motor function state of the UL, pain intensity, cognitive functions, general physical and emotional status. An integral indicators are the assessment of the patient's quality of life and independence in everyday life activity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| digital interactive technology Smart glove "SensoRehab" | Experimental | The operation of the digital interactive complex Smart glove "SensoRehab" is based on the visual and kinesthetic (proprioceptive) biofeedback principle by using a set of cognitive interactive computer games controlled by finger and hand movements. The technique involves neurosensory training and retraining to improve the fine use of the hand and arm, and the patient's cognitive and emotional state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital interactive technology Smart glove "SensoRehab" | Device | Participants will receive rehabilitation program including sessions on the Smart glove "SensoRehab" (SGSR) system. The program for IS patients includes 10 sessions with the SGSR: 15-30 minutes once a day for the affected hand, 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic | The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy. | Baseline, end of the 2-nd week |
| Fugl-Meyer Upper Extremity Scale (FMA-UE) dynamic | The FMA UE Scale comprises 33 items, each scored on a scale of0 to 2, where 0 = cannot perform, 1 = performs partially and2 = performs fully. It is free, requires only household items fortesting, and takes up to 30 minutes to administer. Changes in sections A-D of the FMA-UE Scale by 7 points or more are considered as efficacy. | Baseline, 1-month after completing training |
| Action Research Arm Test (ARAT) Scale dynamic | The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy. | Baseline, end of the 2-nd week |
| Action Research Arm Test (ARAT) Scale dynamic | The Action Research Arm Test (ARAT) is a 19 item observational measures. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Changes in the total ARAT Scale score by 4 points or more more are considered as efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of correctly performed tasks | percentage of correctly performed tasks while training | Baseline, end of the 2-nd week |
| change in the paresis degree The 6-point Medical Research Council Scale for assessing muscle strength: MRCS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liudmila V Petrova, PhD | Contact | +79163940742 | ludmila.v.petrova@yandex.ru | |
| Elena V Kostenko, MD | Contact | +79057685856 | ekostenko58@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Elena V Kostenko, MD | Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, branch 7 | Recruiting | Moscow | 105120 | Russia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 7, 2023 | |
| Reset | Nov 16, 2023 |
Not provided
an open-label observational trial
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 1-month after completing training |
The 6-point Medical Research Council Scale for assessing
| Baseline, end of the 2-nd week and 1-month after completing training |
| changes in spasticity severity | Modified Ashworth Scale: MAS (0 to 4 points) | Baseline, end of the 2-nd week and 1-month after completing training |
| changes in level of impairment or dependence in daily life | Barthel ADL Index | Baseline, end of the 2-nd week and 1-month after completing training |
| сhanges in cognitive status | Montreal Cognitive Assessment: МоСА | Baseline, end of the 2-nd week and 1-month after completing training |
| Presence and severity of depression | The Hospital Anxiety and Depression Scale: HADS. Changes in HADS anxiety and depression scores | Baseline, end of the 2-nd week and 1-month after completing training |
| Life quality assessment | European Quality of Life Questionnaire EuroQol EQ-5D-5L (version 1.0, 2011 in combination with the visual analogue scale) | Baseline, end of the 2-nd week and 1-month after completing training |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 7, 2023 | Nov 16, 2023 |