Pronation ContractureSupPro BotoxNCT00900692

Dynamic Splinting for Excessive Pronation Following CVA

A study testing Dynasplint in people with Pronation Contracture, run by Dynasplint Systems, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pronation Contracture
What is being tested?: Dynasplint
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: May 2009to Oct 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms:
Pronation Contracture
Ability to provide consent and follow directions as related to the protocol

Who cannot join

Treatment with Benzodiazepines
Treatment with Baclofen (pump or oral)
Treatment with Dantrolene sodium
Treatment with Tizanidine

Trial locations and contacts

1 site in 1 country.

United States1 site

Rehabilitation Associates of Indiana
Indianapolis, Indiana, 46250

Other trials in United States

About this study

Official title: Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial

The purpose of this study is to examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint.

Conditions: Pronation Contracture
Being tested: Dynasplint
Keywords: Excessive pronation, CVA, Forearm, Excessive pronation following CVA

What participants receive

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

DynasplintDevice
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen

Study groups in NCT00900692
Study group	Role	What they receive
Dynasplint Group	Experimental	Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day Receives: Device: Dynasplint
Standard of care	No intervention	Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions.

What is being measured

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

ROM changes with use of treatment
Measured: 20 weeks

Timeline

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

May 2009Oct 2016

First posted13 May 2009 (estimated)
Study startMay 2009
Primary completionSep 2016 (estimated)
Study completionOct 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Pronation ContractureStudies 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: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00900692
Sponsor's protocol ID: 2009.001
Acronym: SupPro Botox
Status last verified: Jul 2013
First submitted: 12 May 2009
Last updated: 11 Jul 2013
Results posted: No
Data monitoring committee: Yes

Publications

Andreasen DS, Aviles AA, Allen SK, Guthrie KB, Jennings BR, Sprigle SH. Exoskeleton for forearm pronation and supination rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:2714-7. doi: 10.1109/IEMBS.2004.1403778.
PubMed 17270837
Winchester P, McColl R, Querry R, Foreman N, Mosby J, Tansey K, Williamson J. Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Neurorehabil Neural Repair. 2005 Dec;19(4):313-24. doi: 10.1177/1545968305281515.
PubMed 16263963
Cooper. Et al. Proceedings of the Stroke Disparities Advisory Panel Meeting, Nov 08, 2002, Bethesda MD, National Institute of Neurological Disorders and Stroke
McKinley W, Tewksbury MA, Sitter P, Reed J, Floyd S. Assistive technology and computer adaptations for individuals with spinal cord injury. NeuroRehabilitation. 2004;19(2):141-6.
PubMed 15201473
Horsley SA, Herbert RD, Ada L. Four weeks of daily stretch has little or no effect on wrist contracture after stroke: a randomised controlled trial. Aust J Physiother. 2007;53(4):239-45. doi: 10.1016/s0004-9514(07)70004-1.
PubMed 18047458
Nuismer BA, Ekes AM, Holm MB. The use of low-load prolonged stretch devices in rehabilitation programs in the Pacific northwest. Am J Occup Ther. 1997 Jul-Aug;51(7):538-43. doi: 10.5014/ajot.51.7.538.
PubMed 9242860
Bloemen-Vrencken JH, de Witte LP, Post MW. Follow-up care for persons with spinal cord injury living in the community: a systematic review of interventions and their evaluation. Spinal Cord. 2005 Aug;43(8):462-75. doi: 10.1038/sj.sc.3101750.
PubMed 15838530
Tsao CC, Mirbagheri MM. Upper limb impairments associated with spasticity in neurological disorders. J Neuroeng Rehabil. 2007 Nov 29;4:45. doi: 10.1186/1743-0003-4-45.
PubMed 18047660
Bryden AM, Kilgore KL, Lind BB, Yu DT. Triceps denervation as a predictor of elbow flexion contractures in C5 and C6 tetraplegia. Arch Phys Med Rehabil. 2004 Nov;85(11):1880-5. doi: 10.1016/j.apmr.2004.01.042.
PubMed 15520985
Lannin NA, Herbert RD. Is hand splinting effective for adults following stroke? A systematic review and methodologic critique of published research. Clin Rehabil. 2003 Dec;17(8):807-16. doi: 10.1191/0269215503cr682oa.
PubMed 14682551
Naik AK, Pathirathna S, Jevtovic-Todorovic V. GABAA receptor modulation in dorsal root ganglia in vivo affects chronic pain after nerve injury. Neuroscience. 2008 Jul 17;154(4):1539-53. doi: 10.1016/j.neuroscience.2008.04.061. Epub 2008 May 3.
PubMed 18554816
Mahmood NS, Kadavigere R, Avinash KR, Rao VR. Magnetic resonance imaging in acute cervical spinal cord injury: a correlative study on spinal cord changes and 1 month motor recovery. Spinal Cord. 2008 Dec;46(12):791-7. doi: 10.1038/sc.2008.55. Epub 2008 Jun 10.
PubMed 18542094
Harvey L, de Jong I, Goehl G, Mardwedel S. Twelve weeks of nightly stretch does not reduce thumb web-space contractures in people with a neurological condition: a randomised controlled trial. Aust J Physiother. 2006;52(4):251-8. doi: 10.1016/s0004-9514(06)70004-6.
PubMed 17132119
Patrick JH, Farmer SE, Bromwich W. Muscle stretching for treatment and prevention of contracture in people with spinal cord injury. Spinal Cord. 2002 Aug;40(8):421-2; author reply 423. doi: 10.1038/sj.sc.3101340. No abstract available.
PubMed 12124669
Lai JM, Francisco GE, Willis FB. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study. Adv Ther. 2009 Feb;26(2):241-8. doi: 10.1007/s12325-008-0139-2. Epub 2009 Feb 4.
PubMed 19194671

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial
ClinicalTrials.gov ID: NCT00900692
Acronym / sponsor ID: SupPro Botox / 2009.001
Conditions: Pronation Contracture
Keywords: Excessive pronation, CVA, Forearm, Excessive pronation following CVA
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Sep 2016 (estimated)
Study completion: Oct 2016 (estimated)
First posted: 13 May 2009 (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 examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint.

Study design

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

Arm	Type	Receives
Dynasplint Group	Experimental	Device: DynasplintAlong with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day
Standard of care	No intervention	–Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms:
Pronation Contracture
Ability to provide consent and follow directions as related to the protocol

Key exclusion criteria (4 listed)

Treatment with Benzodiazepines
Treatment with Baclofen (pump or oral)
Treatment with Dantrolene sodium
Treatment with Tizanidine

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
DynasplintDynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen	Device	Dynasplint Group

Primary outcome

ROM changes with use of treatment
Time frame: 20 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
Background: PubMed 17270837Andreasen DS, Aviles AA, Allen SK, Guthrie KB, Jennings BR, Sprigle SH. Exoskeleton for forearm pronation and supination rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:2714-7. doi: 10.1109/IEMBS.2004.1403778.
Background: PubMed 16263963Winchester P, McColl R, Querry R, Foreman N, Mosby J, Tansey K, Williamson J. Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Neurorehabil Neural Repair. 2005 Dec;19(4):313-24. doi: 10.1177/1545968305281515.
BackgroundCooper. Et al. Proceedings of the Stroke Disparities Advisory Panel Meeting, Nov 08, 2002, Bethesda MD, National Institute of Neurological Disorders and Stroke
Background: PubMed 15201473McKinley W, Tewksbury MA, Sitter P, Reed J, Floyd S. Assistive technology and computer adaptations for individuals with spinal cord injury. NeuroRehabilitation. 2004;19(2):141-6.
Background: PubMed 18047458Horsley SA, Herbert RD, Ada L. Four weeks of daily stretch has little or no effect on wrist contracture after stroke: a randomised controlled trial. Aust J Physiother. 2007;53(4):239-45. doi: 10.1016/s0004-9514(07)70004-1.
Background: PubMed 9242860Nuismer BA, Ekes AM, Holm MB. The use of low-load prolonged stretch devices in rehabilitation programs in the Pacific northwest. Am J Occup Ther. 1997 Jul-Aug;51(7):538-43. doi: 10.5014/ajot.51.7.538.
Background: PubMed 15838530Bloemen-Vrencken JH, de Witte LP, Post MW. Follow-up care for persons with spinal cord injury living in the community: a systematic review of interventions and their evaluation. Spinal Cord. 2005 Aug;43(8):462-75. doi: 10.1038/sj.sc.3101750.
Background: PubMed 18047660Tsao CC, Mirbagheri MM. Upper limb impairments associated with spasticity in neurological disorders. J Neuroeng Rehabil. 2007 Nov 29;4:45. doi: 10.1186/1743-0003-4-45.
Background: PubMed 15520985Bryden AM, Kilgore KL, Lind BB, Yu DT. Triceps denervation as a predictor of elbow flexion contractures in C5 and C6 tetraplegia. Arch Phys Med Rehabil. 2004 Nov;85(11):1880-5. doi: 10.1016/j.apmr.2004.01.042.
Background: PubMed 14682551Lannin NA, Herbert RD. Is hand splinting effective for adults following stroke? A systematic review and methodologic critique of published research. Clin Rehabil. 2003 Dec;17(8):807-16. doi: 10.1191/0269215503cr682oa.
Background: PubMed 18554816Naik AK, Pathirathna S, Jevtovic-Todorovic V. GABAA receptor modulation in dorsal root ganglia in vivo affects chronic pain after nerve injury. Neuroscience. 2008 Jul 17;154(4):1539-53. doi: 10.1016/j.neuroscience.2008.04.061. Epub 2008 May 3.
Background: PubMed 18542094Mahmood NS, Kadavigere R, Avinash KR, Rao VR. Magnetic resonance imaging in acute cervical spinal cord injury: a correlative study on spinal cord changes and 1 month motor recovery. Spinal Cord. 2008 Dec;46(12):791-7. doi: 10.1038/sc.2008.55. Epub 2008 Jun 10.

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.

Marc E Duerden, MD principal investigator

Rehabilitation Associates of Indiana

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

Questions about this trial

What is this clinical trial studying?

A study testing Dynasplint in people with Pronation Contracture, run by Dynasplint Systems, Inc. at 1 site in United States.

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 4 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: withdrawn, as of the sponsor's last update on 11 Jul 2013. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

ROM changes with use of treatment (time frame: 20 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 NCT00900692, which also lists 15 linked publications.

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 11 Jul 2013.