Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power RobotBV108/RAPPHCNNCT06708065

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

A study testing Armeo Power robot restores upper limb motor function., A Home Exercise Program and Occupational therapy activities in people with Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power Robot, run by Hanoi Medical University at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power Robot
What is being tested?: Armeo Power robot restores upper limb motor function., A Home Exercise Program and Occupational therapy activities
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteVietnam
Study dates: 1 Jul 2023to 30 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

108 Military Central Hospital
Hanoi, Hanoi, 120700

Other trials in Vietnam

About this study

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

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
Being tested: Armeo Power robot restores upper limb motor function., A Home Exercise Program, Occupational therapy activities
Keywords: robot Armeo Power, upper extremity function, rehabilitation, ischemic stroke
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
A Home Exercise ProgramBehavioural
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
Occupational therapy activitiesBehavioural
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.

Study groups in NCT06708065
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: A Home Exercise Program; Behavioral: Occupational therapy activities

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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) is a clinical scale designed to assess upper limb function, encompassing both gross motor skills and fine motor skills of the hand and fingers. The test evaluates four primary categories of movement: grasping large objects, grasping medium-sized objects, pinching small objects, and gross arm movements. The maximum score for the ARAT is 57 points, with recovery outcomes classified into three levels: good recovery (57 points), indicating full restoration of function; moderate recovery (10-56 points), reflecting partial functional ability; and poor recovery (<10 points), signifying severe impairment.
Measured: 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
The Hand Movement Scale (HMS) is a clinical tool used to evaluate the motor function of the hand and fingers. The scale is divided into six levels, with scores ranging from 1 to 6, corresponding to increasing levels of movement and dexterity. The scoring reflects progression from no movement (1 point) to the highest level, which is the ability to oppose the thumb (digit I) to the other fingers (6 points). The HMS results are categorized into two levels: poor function (1-3 points) and good function (4-6 points)
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202330 Aug 2024

First posted27 Nov 2024
Study start1 Jul 2023
Primary completion30 Jun 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rehabilitation of Upper Limb Motor Function in Hemiplegia Due to Supratentorial Cerebral Infarction Using Armeo Power RobotStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06708065
Sponsor's protocol ID: 1139/GCN-HMUIRB
Acronym: BV108/RAPPHCN
Status last verified: Nov 2024
First submitted: 24 Nov 2024
Last updated: 27 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06708065
Acronym / sponsor ID: BV108/RAPPHCN / 1139/GCN-HMUIRB
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Hanoi Medical UniversityUniversity, hospital or other
Collaborators: The 108 Military Central Hospital
Study start: 1 Jul 2023 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 27 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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)

Arm	Type	Receives
ARMEO group	Experimental	Device: Armeo Power robot restores upper limb motor function., Behavioral: A Home Exercise Program, Behavioral: Occupational therapy activitiesThe 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.
Control group	Active comparator	Behavioral: A Home Exercise Program, Behavioral: Occupational therapy activitiesThe 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.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Armeo Power robot restores upper limb motor function.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.	Device	ARMEO group
A Home Exercise ProgramA 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	Behavioural	ARMEO group, Control group
Occupational therapy activitiesOccupational 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.	Behavioural	ARMEO group, Control group

Primary outcome

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

2 secondary outcomes

Action Research Arm Test
Time frame: 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
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of upper limb motor function improvement according to 3 scales: FMA-UE, ARAT and HMS in 2 study groups. (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06708065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.