Effect of Hand Rehabilitation Robot on Acute Stroke

January 28, 2025 updated by: burak menek, Istanbul Medipol University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • NP Istanbul Hospital
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: 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.
From enrollment to the end of treatment at 8 weeks
ABILHAND
Time Frame: 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.
From enrollment to the end of treatment at 8 weeks
DASH
Time Frame: 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.
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nine Hole Peg Test
Time Frame: 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.
From enrollment to the end of treatment at 8 weeks
The Modified Ashworth Scale
Time Frame: 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.
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Burak Menek, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2024

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

January 5, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-202.302-620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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