Clinical trial NCT06805955: Effect of Hand Rehabilitation Robot on Acute Stroke
Official title: The Effect of Hand Rehabilitation Robot on Functionality and Activities of Daily Living in Acute Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Keywords: stroke
motor function
fine motor skills
hand robot
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Barthel Index
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: ABILHAND
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: DASH
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Nine Hole Peg Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: The Modified Ashworth Scale
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
city: Istanbul
country: Turkey
facility: NP Istanbul Hospital
Study officials:
affiliation: Medipol University
name: Burak Menek
role: PRINCIPAL_INVESTIGATOR
References: