Effect of Hand Rehabilitation Robot on Acute Stroke

NCT06805955 | Completed

• 1 other identifier: E-10840098-202.302-620
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Rehabilitation

Keywords

stroke; motor function; fine motor skills; hand robot

Outcome Measures

Primary Outcomes (3)

• Barthel Index

  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.

  From enrollment to the end of treatment at 8 weeks

• ABILHAND

  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.

  From enrollment to the end of treatment at 8 weeks

• DASH

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Nine Hole Peg Test

  From enrollment to the end of treatment at 8 weeks

• The Modified Ashworth Scale

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Neurodevelopmental Group

ACTIVE COMPARATOR

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.

Other: NDT

Hand Robot Group

EXPERIMENTAL

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.

Other: NDT+Hand Robot

Interventions

NDT 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.

Neurodevelopmental Group

NDT+Hand Robot 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.

Hand Robot Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (2)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

NP Istanbul Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Burak Menek

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: January 27, 2024
• Primary Completion: November 15, 2024
• Study Completion: January 5, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)