Effect of Hand Rehabilitation Robot on Acute Stroke

NCT ID: NCT06805955

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-27
• Study Completion Date: 2025-01-05

Brief Summary

This study aimed to evaluate the effectiveness of hand robot-assisted therapy on functionality, fine motor skills, and activities of daily living (ADLs) in acute stroke rehabilitation. A total of 30 participants aged 40-60 years with a diagnosis of stroke were randomly assigned to two groups: a neurodevelopmental treatment (NDT) group (n=15) and a hand robot-assisted therapy group (n=15). The NDT group received a standard rehabilitation program, including strengthening, stretching, and fine motor activities, three times per week for 8 weeks. The hand robot group received the same NDT program with the addition of hand robot therapy sessions three times per week for 8 weeks.

Outcome measures included the ABILHAND Stroke Questionnaire for hand function, the Barthel Index (BI) for ADLs, the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire for functionality, the Nine-Hole Peg Test (NHPT) for fine motor skills, and the Modified Ashworth Scale (MAS) for spasticity. Both groups showed significant improvements in ADLs, fine motor skills, and ABILHAND scores after treatment (p<0.05). The hand robot group demonstrated superior improvements in BI and NHPT scores compared to the NDT group (p<0.05), while other parameters showed comparable results between groups.

Hand robot-assisted therapy may serve as a complementary approach to neurodevelopmental treatment in individuals with acute stroke.

Detailed Description

This study aimed to investigate the effectiveness of hand robot-assisted therapy on functionality, fine motor skills, and activities of daily living (ADLs) in individuals undergoing acute stroke rehabilitation. A total of 30 participants, aged 40-60 years and diagnosed with stroke, were randomly assigned into two groups: a neurodevelopmental treatment (NDT) group (n=15) and a hand robot-assisted therapy group (n=15).

The NDT group participated in a rehabilitation program consisting of strengthening, stretching, and fine motor activities, administered three times per week for 8 weeks. The hand robot-assisted therapy group received the same NDT program with the addition of hand robot therapy, performed three times per week for 8 weeks immediately after the NDT sessions.

Several assessment tools were used to evaluate outcomes: the ABILHAND Stroke Questionnaire for hand function, the Barthel Index (BI) for ADLs, the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire for functionality, the Nine-Hole Peg Test (NHPT) for fine motor skills, and the Modified Ashworth Scale (MAS) for spasticity. Baseline characteristics, including age, sex, and stroke duration, were homogeneously distributed between groups.

Both groups exhibited significant improvements in ADLs, fine motor activities, ABILHAND scores, and NHPT results post-treatment compared to baseline (p<0.05). However, the hand robot-assisted therapy group demonstrated significantly greater improvements in BI and NHPT scores compared to the NDT group (p<0.05). For other parameters, both groups showed similar outcomes.

These findings suggest that hand robot-assisted therapy can be effectively utilized as a complementary approach to neurodevelopmental treatment in acute stroke rehabilitation, particularly in enhancing ADLs and fine motor skills.

Conditions

Stroke; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurodevelopmental Group

A total of 30 participants meeting inclusion criteria were divided into two groups: the Neurodevelopmental Treatment (NDT) Group (n=15) and the Hand Robot Group (n=15). Both groups completed 24 sessions over 8 weeks (3 days/week, 60 minutes/session). The NDT Group received neurodevelopmental treatment, while the Hand Robot Group received 35 minutes of NDT plus 25 minutes of hand robot-assisted therapy.The NDT program included exercises to reduce muscle tone, improve hand function, and enhance fine motor skills and daily living activities. Specific tasks involved finger and wrist movements, elbow and shoulder mobilizations, PNF exercises, and functional activities like door handle turning and zipper-pulling. Exercises were adapted to patient ability with 10 repetitions per task.Both groups received 15 minutes of electrical stimulation targeting deltoid, biceps, or forearm flexors after each session to enhance muscle strength.

Group Type: ACTIVE_COMPARATOR

NDT

Intervention Type: OTHER

The neurodevelopmental therapy program aimed to reduce muscle tone, improve hand functions, enhance fine motor skills, and support daily living activities such as eating and personal care.

Specific exercises included:

Finger and wrist flexion/extension, Shoulder and elbow stretching and mobilization, PNF exercises, Functional tasks like screw and nut manipulation, Velcro tasks, door handle turning, button pressing, zipper pulling, and laundry peg placement/removal.

Hand Robot Group

In this group, participants received 25 minutes of therapy using the hand robot following neurodevelopmental treatment sessions. After the hand robot therapy, participants performed exercises designed to enhance fine motor skills. The fine motor activities included:

Picking up buttons from one container and placing them into another empty container.

Opening a loosely closed jar lid by gripping it with the help of the hand robot.

Stacking checkers pieces on top of each other on an empty table. Picking up 5 cards from a table, flipping them over, and placing them back on the table.

Grasping small weighted cubes from one table and transferring them to another table of a different height.

These exercises were aimed at improving hand function and fine motor coordination.

Group Type: EXPERIMENTAL

NDT+Hand Robot

Intervention Type: OTHER

In this group, participants received 25 minutes of hand robot-assisted therapy following neurodevelopmental treatment. After the robot therapy, they performed fine motor skill exercises, including:

Picking up buttons from one container and placing them in another, Opening a loosely closed jar lid using the robot, Stacking checkers pieces on a table, Flipping over and placing cards back on the table, Transferring weighted cubes from one table to another at a different height. These activities aimed to improve fine motor coordination and hand functionality.

Interventions

NDT

The neurodevelopmental therapy program aimed to reduce muscle tone, improve hand functions, enhance fine motor skills, and support daily living activities such as eating and personal care.

Specific exercises included:

Finger and wrist flexion/extension, Shoulder and elbow stretching and mobilization, PNF exercises, Functional tasks like screw and nut manipulation, Velcro tasks, door handle turning, button pressing, zipper pulling, and laundry peg placement/removal.

Intervention Type: OTHER

NDT+Hand Robot

In this group, participants received 25 minutes of hand robot-assisted therapy following neurodevelopmental treatment. After the robot therapy, they performed fine motor skill exercises, including:

Picking up buttons from one container and placing them in another, Opening a loosely closed jar lid using the robot, Stacking checkers pieces on a table, Flipping over and placing cards back on the table, Transferring weighted cubes from one table to another at a different height. These activities aimed to improve fine motor coordination and hand functionality.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals aged 40-60 diagnosed with stroke
• Possession of adequate communication skills
• A score of at least 20 or higher on the Mini-Mental State Examination
• Full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints
• Spasticity score of 2 or below in the elbow, wrist, and finger flexor muscles according to the Modified Ashworth Scale
• Upper extremity muscle strength between 2+ and 4
• Stroke duration not exceeding 6 weeks

Exclusion Criteria

• Inability to meet the study requirements due to insufficient verbal or written communication skills
• Presence of deformities that prevent participation in exercise
• Additional diagnoses of cardiovascular, rheumatologic, or orthopedic conditions
• Individuals who have undergone surgery within the past 6 months were excluded from the study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

burak menek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burak Menek

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

NP Istanbul Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-202.302-620

Identifier Type: -

Identifier Source: org_study_id