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SuspendedNCT02636205Updated Oct 13, 2016

The Use of Armeo Spring in Upper Extremity Rehabilitation

An interventional study of Armeo therapy in Hemiplegia, Cerebral Palsy and Upper Extremity Weakness, sponsored by St Mary's Hospital for Children. Suspended. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-10-13.

Sponsored by St Mary's Hospital for Children · Not applicable, Interventional, and Treatment

Why this study was suspended
Primary investigator changed. Study protocol may under go change with addition of new investigators.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
7 Years to 17 Years
Sex
All
01

Study 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. 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
  1. "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.
  1. "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.
  1. "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.
02

Conditions studied

  • Hemiplegia
  • Cerebral Palsy
  • Upper Extremity Weakness
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 15 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

St Mary's Hospital for Children is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Armeo

    Group receiving Armeo therapy

    Device: Armeo therapy

Interventions

  • DeviceArmeo therapy

    Participants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks.

06

What researchers measure

Primary outcomes

  1. Change in hand function

    Box and Blocks test

    Time frame: baseline and completion (6-8 weeks)

  2. Change in hand function

    Jebsen Taylor Hand Function Test

    Time frame: baseline and completion (6-8weeks)

  3. Change in bimanual hand function

    Assisting hand Assessment

    Time frame: baseline and completion (6-8 weeks)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02636205
Lead sponsor
St Mary's Hospital for Children
Responsible party
Swetha Krishnaswamy (Occupational Therapist, St Mary's Hospital for Children) — Principal investigator
First posted
Dec 21, 2015
Start date
Jul 2014
Primary completion
Sep 2016
Completion
Dec 2016 (estimated)
Last update
Oct 13, 2016

Study contacts

Swetha Krishnaswamy, MS OTR/L
principal investigator · St Mary's Hospital for Children

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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