Effects of Armeo Power Robot Therapy on Upper Limb Recovery in Hemiplegic Stroke Patients

NCT06708065 | Completed FDA Device

• 1 other identifier: 1139/GCN-HMUIRB
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Comparison of upper limb motor function improvement according to 3 scales: FMA-UE, ARAT and HMS in 2 study groups.

  The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a standardized clinical test used to evaluate the recovery of upper limb motor function in patients after a stroke. This scale is widely recognized for its reliability and sensitivity in assessing motor recovery during rehabilitation. The test comprises 8 assessment domains with a total of 33 items, and the maximum score achievable is 66 points. Based on the total score, recovery is categorized into four levels: good (56-66 points), indicating near-complete recovery of motor function; fair (42-54 points), reflecting moderate recovery; average (22-40 points), representing limited recovery with partial functionality; and poor (0-20 points), signifying severe motor impairment

  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 (2)

• Action Research Arm Test

  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.

• Hand Movement scale

  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.

Study Arms (2)

ARMEO group

EXPERIMENTAL

The intervention group consisted of 42 patients who received standard physical therapy and occupational therapy for 90 minutes per day, five days per week. Additionally, these patients underwent training with the ArmeoPower robotic system for 45 minutes per day, five days per week.

Device: Armeo Power robot restores upper limb motor function.; Behavioral: A Home Exercise Program; Behavioral: Occupational therapy activities

Control group

ACTIVE COMPARATOR

The control group comprised 42 patients who participated in standard physical therapy and occupational therapy for 90 minutes per day, five days per week. In addition, these patients were instructed to engage in home-based practice for 45 minutes per day, five days per week, guided by direct instructions and exercise leaflets provided by the therapists.

Behavioral: A Home Exercise Program; Behavioral: Occupational therapy activities

Interventions

Armeo Power robot restores upper limb motor function. DEVICE

ArmeoPower is a robotic rehabilitation device developed by Hocoma, designed to assist patients with impaired upper limb motor functions following conditions such as stroke or neurological injuries. The device features an exoskeleton that supports and tracks movements of the arm and hand, utilizing motor-assisted motion based on the principle of "adaptive support," which adjusts assistance levels according to the patient's capabilities. ArmeoPower integrates interactive exercises, often in the form of engaging games, to enhance patient motivation and maintain focus during therapy sessions. It also collects and tracks performance data, enabling clinicians to evaluate progress over time. This device is widely used in rehabilitation centers and hospitals to improve muscle control, strength, and range of motion in patients recovering from severe motor impairments.

ARMEO group

A Home Exercise Program BEHAVIORAL

A Home Exercise Program (HEP) is a personalized set of exercises designed to support recovery and enhance functional abilities outside of clinical therapy sessions. For patients with hemiplegia due to cerebral infarction, the program typically includes range of motion (ROM) exercises to maintain joint flexibility and prevent stiffness, as well as strengthening exercises using resistance bands or light weights to improve muscle function. Balance and postural control exercises, such as weight shifting or standing on one leg, help enhance stability and reduce fall risks. Functional training focuses on practicing daily movements like reaching, grasping, or transferring between positions, while fine motor skill tasks aim to restore hand functionality. The program may also incorporate low-impact aerobic exercises, such as walking or seated cycling, to boost cardiovascular health, along with relaxation and breathing techniques to reduce stress and improve overall well-being. These exercises a

ARMEO group; Control group

Occupational therapy activities BEHAVIORAL

Occupational therapy activities are designed to help individuals regain independence in daily life by addressing functional abilities, motor skills, and cognitive functions. For patients with hemiplegia due to cerebral infarction, these activities often include practicing Activities of Daily Living (ADLs) such as dressing, grooming, bathing, and feeding, as well as more complex tasks like cooking and managing finances. Fine motor skills development is emphasized through exercises involving tasks like buttoning, tying shoelaces, or handling small objects, sometimes using adaptive tools. Additionally, functional mobility training focuses on teaching safe movement strategies, such as transferring between surfaces or navigating stairs, and may include wheelchair mobility or energy conservation techniques. These activities are tailored to the patient's needs to enhance their ability to perform meaningful and necessary daily tasks independently.

ARMEO group; Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead
• The 108 Military Central Hospital: collaborator

Study Sites (1)

108 Military Central Hospital

Hanoi, Hanoi, 120700, Vietnam

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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)

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

VN (1)