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Clinical Trials/NCT06805955
NCT06805955CompletedNot Applicable

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

Istanbul Medipol University Hospital2 sites in 1 country30 target enrollmentStarted: January 27, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Barthel Index

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: NDT (Other)

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.

Intervention: NDT+Hand Robot (Other)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Istanbul Medipol University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

burak menek

Principal Investigator

Istanbul Medipol University Hospital

Study Sites (2)

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