HemiparesisNCT02729649
ArmAssist Robotic Device for Arm Training
A study testing ArmAssist robotic training, Conventional therapy and Extended conventional therapy in people with Hemiparesis, run by University of Belgrade at 1 site in Serbia.
Trial summary
ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemiparesis
- What is being tested?
- ArmAssist robotic training, Conventional therapy and Extended conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2016to Dec 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral paresis;
- ability to understand and follow simple instructions;
- minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints.
Who cannot join
- bilateral impairment;
- severe sensory deficits in the paretic upper limb;
- cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment;
- inability to provide informed consent;
- other current severe medical problems.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000
About this study
ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.
- Conditions
- Hemiparesis
- Being tested
- ArmAssist robotic training, Conventional therapy, Extended conventional therapy
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmAssist robotic trainingDevice
Conventional therapyOther
Extended conventional therapyOther
| Study group | Role | What they receive |
|---|---|---|
| ArmAssist therapy | Experimental | The group will be treated with ArmAssist robot therapy. Receives: Device: ArmAssist robotic training; Other: Conventional therapy |
| Conventional therapy | Active comparator | The group will be treated with conventional therapy. Receives: Other: Conventional therapy |
| Extended Conventional therapy | Active comparator | The group will be treated with extended conventional therapy. Receives: Other: Conventional therapy; Other: Extended conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Mayer motor score for upper extremity
Measured: 4 weeks
Secondary outcomes (4)
Ashworth score
Measured: 4 weeks
Action research arm score
Measured: 4 weeks
Wolf motor function test
Measured: 4 weeks
Barthel index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiparesisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinovic Ljubica, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729649
- Sponsor's protocol ID
- LK-3
- Status last verified
- Nov 2023
- First submitted
- 29 Mar 2016
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tomic TJ, Savic AM, Vidakovic AS, Rodic SZ, Isakovic MS, Rodriguez-de-Pablo C, Keller T, Konstantinovic LM. ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial. Biomed Res Int. 2017;2017:7659893. doi: 10.1155/2017/7659893. Epub 2017 Jan 31.
PubMed 28251157
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArmAssist Robotic Device for Arm Training
- ClinicalTrials.gov ID
- NCT02729649
- Acronym / sponsor ID
- LK-3
- Conditions
- Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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.
ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ArmAssist therapy | Experimental | Device: ArmAssist robotic training, Other: Conventional therapyThe group will be treated with ArmAssist robot therapy. |
| Conventional therapy | Active comparator | Other: Conventional therapyThe group will be treated with conventional therapy. |
| Extended Conventional therapy | Active comparator | Other: Conventional therapy, Other: Extended conventional therapyThe group will be treated with extended conventional therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral paresis;
- ability to understand and follow simple instructions;
- minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints.
Key exclusion criteria (5 listed)
- bilateral impairment;
- severe sensory deficits in the paretic upper limb;
- cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment;
- inability to provide informed consent;
- other current severe medical problems.
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 |
|---|---|---|
| ArmAssist robotic training | Device | ArmAssist therapy |
| Conventional therapy | Other | ArmAssist therapy, Conventional therapy, Extended Conventional therapy |
| Extended conventional therapy | Other | Extended Conventional therapy |
Primary outcome
Fugl Mayer motor score for upper extremity
Time frame: 4 weeks
4 secondary outcomes
Ashworth score
Time frame: 4 weeks
Action research arm score
Time frame: 4 weeks
Wolf motor function test
Time frame: 4 weeks
Barthel index
Time frame: 4 weeks
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 30 Nov 2023.
- Derived from this study: PubMed 28251157Tomic TJ, Savic AM, Vidakovic AS, Rodic SZ, Isakovic MS, Rodriguez-de-Pablo C, Keller T, Konstantinovic LM. ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial. Biomed Res Int. 2017;2017:7659893. doi: 10.1155/2017/7659893. Epub 2017 Jan 31.
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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?
A study testing ArmAssist robotic training, Conventional therapy and Extended conventional therapy in people with Hemiparesis, run by University of Belgrade at 1 site in Serbia.
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 3 inclusion and 5 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 30 Nov 2023. 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 Serbia. 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?
Fugl Mayer motor score for upper extremity (time frame: 4 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 NCT02729649, which also lists 1 linked publication.
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 30 Nov 2023.