HemiplegiaNCT02636205
The Use of Armeo Spring in Upper Extremity Rehabilitation
A study testing Armeo therapy in people with Hemiplegia and Cerebral Palsy, run by St Mary's Hospital for Children.
Trial summary
The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the weight of the child's arm and uses joystick that helps to play computer games. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Hemiplegia, Cerebral Palsy, Upper Extremity Weakness
- What is being tested?
- Armeo therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 7 -17 years.
- Arm weakness secondary to various causes.
- Armeo®Spring Pediatric fit
- Upper arm measures:155mm-235mm (7 to 9.5 inches)
- Lower arm measures: 230mm-370mm (9inches to 14 inches)
- Ability to follow instructions.
Who cannot join
- Vision deficits
- Contractures that do not allow use of system.
- Spasticity that does not allow use of system.
- Osteopenia
- Recent surgeries to the involved upper extremity.
About this study
The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the weight of the child's arm and uses joystick that helps to play computer games. The child will be assessed before and after this therapy. Participating children with upper extremity impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions at progressively increasing degrees of difficulty. Each child's performance will be tracked with regard to time necessary to complete a predetermined number of trials of the activity. The standardized assessment tools that will be used are the Assisting Hand Assessment (AHA), Box \& Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine the efficacy of this training method.
Read the detailed description
- "Adverse Events" All serious adverse events will be reported to the IRB immediately, but no later than [5] days of the occurrence or receipt of notification from an outside source; the IRB can make changes to the consent form as a result of adverse events. Any such event will be reported to the IRB on the "Adverse Event Report." [See attachment.] 9. "Debriefing" Debriefing is not required because there is no deception of subjects involved or there are no alternative treatments or procedures used in a "blind" fashion.
- "Intervention" Participants in this study are children who present with a diagnosis of upper extremity weakness or involvement secondary to various reasons. These children receive occupational, physical, and/or speech services at St Mary's Hospital for Children. The children participating in this program will be receiving their occupational therapy session with the use of the Armeo®Spring Pediatric. They will also continue to receive their regular physical and speech therapy session. Once the program is completed, they will continue to receive their regular occupation therapy sessions.
- "Confidentiality" Data sheets will be coded with a number to represent each child. The numeric data obtained regarding timed trials will be entered into a computer which is password-protected at St. Mary's Hospital for Children in Bayside, NY. Consent forms with the child's name and parental signatures and video tape or photographic images recorded during data collection will be stored in accordance with St. Mary's Hospital for Children patient privacy policy.
- Conditions
- Hemiplegia, Cerebral Palsy, Upper Extremity Weakness
- Being tested
- Armeo therapy
- Medical subject headings
- Hemiplegia, Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo therapyDevice
Participants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks.
| Study group | Role | What they receive |
|---|---|---|
| Armeo | Experimental | Group receiving Armeo therapy Receives: Device: Armeo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hand function
Box and Blocks test
Measured: baseline and completion (6-8 weeks)
Change in hand function
Jebsen Taylor Hand Function Test
Measured: baseline and completion (6-8weeks)
Change in bimanual hand function
Assisting hand Assessment
Measured: baseline and completion (6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionDec 2016 (estimated)
Why it stopped: Primary investigator changed. Study protocol may under go change with addition of new investigators.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swetha Krishnaswamy, St Mary's Hospital for Children
- Investigators
- Swetha Krishnaswamy, MS OTR/L, Principal investigator, St Mary's Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636205
- Sponsor's protocol ID
- 2014-01
- Status last verified
- Oct 2016
- First submitted
- 15 Dec 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Armeo Spring in Upper Extremity Rehabilitation
- ClinicalTrials.gov ID
- NCT02636205
- Acronym / sponsor ID
- 2014-01
- Conditions
- Hemiplegia, Cerebral Palsy, Upper Extremity Weakness
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Primary investigator changed. Study protocol may under go change with addition of new investigators.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- St Mary's Hospital for ChildrenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Dec 2015 (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.
The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the weight of the child's arm and uses joystick that helps to play computer games. The child will be assessed before and after this therapy. Participating children with upper extremity impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions at progressively increasing degrees of difficulty. Each child's performance will be tracked with regard to time necessary to complete a predetermined number of trials of the activity. The standardized assessment tools that will be used are the Assisting Hand Assessment (AHA), Box \& Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine the efficacy of this training method.
Detailed description
- "Adverse Events" All serious adverse events will be reported to the IRB immediately, but no later than [5] days of the occurrence or receipt of notification from an outside source; the IRB can make changes to the consent form as a result of adverse events. Any such event will be reported to the IRB on the "Adverse Event Report." [See attachment.] 9. "Debriefing" Debriefing is not required because there is no deception of subjects involved or there are no alternative treatments or procedures used in a "blind" fashion.
- "Intervention" Participants in this study are children who present with a diagnosis of upper extremity weakness or involvement secondary to various reasons. These children receive occupational, physical, and/or speech services at St Mary's Hospital for Children. The children participating in this program will be receiving their occupational therapy session with the use of the Armeo®Spring Pediatric. They will also continue to receive their regular physical and speech therapy session. Once the program is completed, they will continue to receive their regular occupation therapy sessions.
- "Confidentiality" Data sheets will be coded with a number to represent each child. The numeric data obtained regarding timed trials will be entered into a computer which is password-protected at St. Mary's Hospital for Children in Bayside, NY. Consent forms with the child's name and parental signatures and video tape or photographic images recorded during data collection will be stored in accordance with St. Mary's Hospital for Children patient privacy policy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Armeo | Experimental | Device: Armeo therapyGroup receiving Armeo therapy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 7 -17 years.
- Arm weakness secondary to various causes.
- Armeo®Spring Pediatric fit
- Upper arm measures:155mm-235mm (7 to 9.5 inches)
- Lower arm measures: 230mm-370mm (9inches to 14 inches)
Key exclusion criteria (5 listed)
- Vision deficits
- Contractures that do not allow use of system.
- Spasticity that does not allow use of system.
- Osteopenia
- Recent surgeries to the involved upper extremity.
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 therapyParticipants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks. | Device | Armeo |
Primary outcome
Change in hand function
Time frame: baseline and completion (6-8 weeks)
Box and Blocks test
Change in hand function
Time frame: baseline and completion (6-8weeks)
Jebsen Taylor Hand Function Test
Change in bimanual hand function
Time frame: baseline and completion (6-8 weeks)
Assisting hand Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: Yes
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
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.
Swetha Krishnaswamy, MS OTR/L principal investigator
St Mary's Hospital for Children
Questions about this trial
What is this clinical trial studying?
A study testing Armeo therapy in people with Hemiplegia and Cerebral Palsy, run by St Mary's Hospital for Children.
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 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: paused, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in hand function (time frame: baseline and completion (6-8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2016.