Effect of Hand Rehabilitation Robot on Acute Stroke

Not Applicable

Completed

• Conditions: Stroke; Rehabilitation

• Registration Number: NCT06805955
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Study Start: 2024-01-27
• Primary Completion: 2024-11-15
• Status Verified: 2025-01
• Study Completion: 2025-01-05
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Barthel Index	From enrollment to the end of treatment at 8 weeks	The 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.
ABILHAND	From enrollment to the end of treatment at 8 weeks	In 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.
DASH	From enrollment to the end of treatment at 8 weeks	The 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 Outcome Measures

Name	Time	Method
Nine Hole Peg Test	From enrollment to the end of treatment at 8 weeks	The 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 Scale	From enrollment to the end of treatment at 8 weeks	The 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.

Trial Locations

Locations (2)

NP Istanbul Hospital; 🇹🇷 Istanbul, Turkey

Istanbul Medipol University; 🇹🇷 Istanbul, Beykoz, Turkey