NCT Number: NCT06805955
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.
Looking for future studies?
Notify Me40 year–60 year
All sexes
Interventional
Not applicable
Istanbul Medipol University, Istanbul, Beykoz, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Istanbul Medipol University Hospital
Other
The Effect of Hand Rehabilitation Robot on Functionality and Activities of Daily Living in Acute Stroke Rehabilitation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07454655
Brain Diseases, Cardiovascular Diseases
Gaziantep, Turkey (Türkiye)
View Trial DetailsNCT07534124
Brain Diseases, Cardiovascular Diseases
Madrid, Spain
View Trial DetailsNCT06501014
Brain Diseases, Cardiovascular Diseases
Konya, Turkey (Türkiye)
View Trial DetailsNCT04637984
Brain Diseases, Cardiovascular Diseases
Ferrara, Emilia-Romagna, Italy
View Trial Details