Effects of Armeo Power Robot Therapy on Upper Limb Recovery in Hemiplegic Stroke Patients (BV108/RAPPHCN)

November 24, 2024 updated by: Tuan Nguyen Thanh, Hanoi Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ha Noi, Vietnam, 120700
        • 108 Military Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARMEO group
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.
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.
Behavioral: A Home Exercise Program
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
Behavioral: Occupational therapy activities
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.
Active Comparator: Control group
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
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
Behavioral: Occupational therapy activities
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanoi Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The 108 Military Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1139/GCN-HMUIRB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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