Clinical trial NCT06708065: Effects of Armeo Power Robot Therapy on Upper Limb Recovery in Hemiplegic Stroke Patients
Official title: Outcomes of Combining Armeo Power Robotic Therapy with Conventional Rehabilitation for Upper Limb Motor Recovery in Patients with Hemiplegia Following Supratentorial Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power Robot
Keywords: robot Armeo Power, upper extremity function, rehabilitation, ischemic stroke
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: The 108 Military Central Hospital
First posted: 2024-11-27
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. 84 hemiplegic patients, diagnosed with supratentorial cerebral infarction, were treated for stable stroke at clinical departments, meeting the inclusion and exclusion criteria.
2. Dividing the intervention group and the control group according to the lottery method of sampling.
3. Intervention content:

   * Control group: 42 patients were assigned to: regular physical therapy and occupational therapy, 90 minutes/day x 5 days/week. In addition, patients were instructed to practice at home 45 minutes/day x 5 days per week (direct instruction combined with distributing leaflets of exercises).
   * Intervention group: 42 patients were assigned to: regular physical therapy and occupational therapy, 90 minutes/day x 5 days/week. In addition, patients were trained with the Armeo Power robot 45 minutes/day, 5 days per week. - The research subjects were examined and evaluated at two points in time:
   * Time 1: Before intervention
   * Time 2: After completing 3 weeks of training (15 sessions)
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of combining Armeo Power robotic therapy with conventional rehabilitation techniques to improve upper limb motor function in patients with hemiplegia caused by supratentorial cerebral infarction (a type of stroke). The study aims to evaluate how robotic-assisted therapy can enhance recovery by measuring motor function improvements over three weeks of treatment. Participants will undergo standard physical and occupational therapy alongside Armeo Power training, with results compared to those receiving only standard rehabilitation. The findings aim to provide valuable insights into advanced therapeutic options for stroke rehabilitation.


Eligibility criteria: Inclusion Criteria

* Spasticity of the affected arm with a Modified Ashworth Scale score ≤ 2.
* Patients must have good cognition and awareness (MoCA score ≥ 26).
* Patients must have good vision and visual perception.
* Patients must have stable sitting posture and good sitting balance.
* Body weight and affected arm size must be compatible with the robotic arm device.
* Patients must agree to participate in the study and adhere to the training protocol.

Exclusion Criteria

* Spasticity with a Modified Ashworth Scale score ≥ 3.
* Severe sensory impairment in the affected limb.
* Patients with arthritis or joint stiffness.
* Hemiplegia caused by conditions other than stroke.
* Pre-existing motor disabilities in the affected limb before the stroke.
* Skin lesions on the limb requiring rehabilitation.
* Uncontrolled epilepsy.

Primary outcomes:
measure: Comparison of upper limb motor function improvement according to 3 scales: FMA-UE, ARAT and HMS in 2 study groups.
timeFrame: There are 2 time points for evaluating the research subjects in both groups: Time 1: before intervention Time 2: After the end of 15 intervention sessions (about 3 weeks)
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: The Action Research Arm Test (ARAT) can be administered at two time points: baseline (initial assessment) and after 3 weeks to evaluate changes in upper limb function over the course of rehabilitation.
measure: Hand Movement scale
timeFrame: can be administered at two time points: baseline (initial assessment) and after 3 weeks to evaluate changes in upper limb function over the course of rehabilitation.
Other outcomes:
Locations:
city: Ha Noi
country: Vietnam
facility: 108 Military Central Hospital
Study officials:
References: