Recovery of Motor Skills With the Use of Artificial Intelligence and Computer Vision

NCT06183970 | Unknown

• 1 other identifier: AssistI01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the impact of algorithms utilizing artificial intelligence technology and computer vision on the recovery of motor functions within the context of rehabilitation practice for patients who have experienced a cerebral stroke.

Conditions

Stroke; Hemiparesis; Spasticity as Sequela of Stroke; Dysmetria

Keywords

Rehabilitation; Artificial intelligence; Computer vision; Motion capture; Assistive technology

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment Scale for upper extremity assessment (FMA-UE)

  In this study, we wiil use 36 items of the upper arm (proximal musculature, FMA-UA), 24 items of wrist and hand (distal musculature, FMA-W/H), 6 items of aspects of coordination, 12 items of aspects of sensation, 24 items of aspects of passive joint movement, 24 items of joint pain. So the maximum total score on this FMA-UE scale was 126 points.

  Change from baseline at 3 weeks

• Muscle strength was assessed using the MRC (Medical Research Council Weakness Scale)

  MRC is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). Paresis is defined as light at compliance with strength 4 points, moderate - 3 points, pronounced - 2 points, rough - 1 point and with - 0 points.

  Change from baseline at 3 weeks

• The Action Research Arm Test (ARAT)

  Is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. MCID has been suggested as 5.7 points

  Change from baseline at 3 weeks

Secondary Outcomes (6)

• The speed of movement of the upper limb

  Change from baseline at 3 weeks

• Accuracy of performed movements

  Change from baseline at 3 weeks

• Total number of repetitions

  Change from baseline at 3 weeks

• The correctness of the exercises

  Change from baseline at 3 weeks

• The number of exercises completed

  Change from baseline at 3 weeks

Study Arms (3)

AssistI patients

EXPERIMENTAL

Patients will receive rehabilitation training using the AsistI software package in conjunction with standard upper limb rehabilitation interventions.

Device: AssistI patients

Habilect patients

ACTIVE COMPARATOR

Patients will receive rehabilitation training using the Habilect software and hardware complex, in addition to standard rehabilitation interventions for the upper limb.

Device: Habilect patients

Conventional therapy patients

NO INTERVENTION

Patients will undergo standard upper limb rehabilitation interventions without the utilization of additional methods.

Interventions

AssistI patients DEVICE

The AsistI software package rehabilitation involves tailored upper limb exercises under an individual program. The regimen consists of 10-12 sessions, each lasting 30 minutes. Patients execute 10 exercises sequentially with their unaffected and affected limbs, involving tasks like touching mouth, forehead, and trunk parts with hand's brush, and amplitude movements in upper limb joints. AsistI assesses exercise accuracy, prevents unfavorable patterns, and logs target achievement, considering speed, accuracy, and repetitions.

AssistI patients

Habilect patients DEVICE

The Habilect rehab program involves 10-12 sessions using software and hardware. Patients perform upper limb exercises for 30 minutes individually, focusing on specific movements. They repeat 10 exercises, first with the healthy limb, then the affected one. Tasks include touching mouth, forehead, and trunk, along with joint movements like shoulder flexion. Habilect assesses exercise accuracy, preventing wrong moves, and tracks progress, considering speed, accuracy, repetitions.

Habilect patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent hemispheric stroke (ischemic or hemorrhagic):
• Rankin scale: 3
• Within 6 months post stroke.
• Upper limb hemiparesis with strength ≤3 points proximally.
• Muscle tone rise (≤3 points) on Ashford scale.
• Complex sensitivity preserved per neuro examination

You may not qualify if:

• Rankin scale of 4 points and higher.
• months or more after undergoing stroke.
• Structural changes in the joints of the upper extremities that limit joint mobility (contractures, ankylosis, metal structures that limit mobility).
• Severe pain syndrome in the paretic upper limb at rest or when moving, preventing exercise (7 points or more on the scale).
• Gross cognitive disorders, psychoemotional arousal, signs of hysteria, pseudobulbar syndrome (violent laughter, crying), aphasic disorders that prevent understanding of the task.
• Visual disturbances that prevent the perception of information (neglect, hemianopia, myopia, diplopia).
• Thrombosis of the veins in the upper and lower extremities without signs of recanalization, or arterial thrombosis.
• Parkinsonism and other types of tremor.

Sponsors & Collaborators

• Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health: lead
• Moscow Technical University of Communications and Informatics: collaborator

MeSH Terms

Conditions

Stroke; Paresis; Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebellar Diseases; Ataxia; Dyskinesias

Study Officials

• Michael Gorodnichev

  Moscow Technical University of Communication and Informatics (MTUCI)

  STUDY CHAIR

• Galina Ivanova, Prof

  Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

  STUDY CHAIR

Central Study Contacts

Danila Lobunko

CONTACT

+79091648192; doctorlobunko@gmail.com

Bogdan Ragulin

CONTACT

+79255053658; 5053658@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: December 28, 2023
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-08