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Effect of Hand Rehabilitation Robot on Acute Stroke

The Effect of Hand Rehabilitation Robot on Functionality and Activities of Daily Living in Acute Stroke Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06805955
Enrollment
30
Registered
2025-02-03
Start date
2024-01-27
Completion date
2025-01-05
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Stroke

Keywords

stroke, motor function, fine motor skills, hand robot

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.

Interventions

OTHERNDT

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.

OTHERNDT+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.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Barthel IndexFrom enrollment to the end of treatment at 8 weeksThe Barthel Index (BI) of Activities of Daily Living is used to assess participants' independence in performing daily activities without assistance. Scored between 0 and 100, the Barthel Index indicates total dependency in the range of 0-20 points, while a score of 100 represents complete independence.
ABILHANDFrom enrollment to the end of treatment at 8 weeksIn the study, the ABILHAND Stroke Hand Function Questionnaire, developed by Penta et al. was used to evaluate hand functions. The assessment examines the level of difficulty participants experience in performing daily tasks such as dressing, household chores, and eating. For the 56 tasks included in the questionnaire, participants are asked to rate their ability based on the past month using the following options: impossible (0 points), difficult (1 point), or easy (2 points) . A higher score indicates better hand function.
DASHFrom enrollment to the end of treatment at 8 weeksThe Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire is used to assess physical limitations and function in upper extremity problems. The DASH questionnaire consists of three subparameters, with the first section comprising 30 questions. Of these, 21 questions evaluate the difficulties patients face in daily life functions, 5 questions assess symptoms, and the remaining 4 questions measure social function, work, sleep, and self-confidence levels.

Secondary

MeasureTime frameDescription
Nine Hole Peg TestFrom enrollment to the end of treatment at 8 weeksThe Nine-Hole Peg Test (NHPT), a timed test validated and reliable for stroke patients, was used to assess hand dexterity and fine motor skills. The test consists of a standard wooden block with 9 pegs (9 mm in diameter) and 9 holes (10 mm in diameter). Participants are instructed to pick up the pegs one by one and place them in the holes on the block as quickly as possible, then remove them individually. The time taken to insert and remove all pegs is recorded. The stopwatch starts when the participant first touches a peg and stops when the last peg is placed back on the table. Patients are allowed to stabilize the wooden block with their non-tested hand.
The Modified Ashworth ScaleFrom enrollment to the end of treatment at 8 weeksThe Modified Ashworth Scale is the most commonly used method for assessing spasticity. The evaluation should be performed while the individual is lying supine in a relaxed position. The joint is moved passively, repeatedly, and rapidly, and the resistance felt during the movement is scored.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026