NCT00900692

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

7.3 years

First QC Date

May 12, 2009

Last Update Submit

July 10, 2013

Conditions

Pronation Contracture

Keywords

Excessive pronationCVAForearmExcessive pronation following CVA

Outcome Measures

Primary Outcomes (1)

  • ROM changes with use of treatment

    20 weeks

Study Arms (2)

Dynasplint Group

EXPERIMENTAL

Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day

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.

Interventions

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

Dynasplint Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Associates of Indiana

Indianapolis, Indiana, 46250, United States

Location

Related Publications (15)

  • 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.

    PMID: 17270837BACKGROUND

  • 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.

    PMID: 16263963BACKGROUND

  • Cooper. Et al. Proceedings of the Stroke Disparities Advisory Panel Meeting, Nov 08, 2002, Bethesda MD, National Institute of Neurological Disorders and Stroke

    BACKGROUND

  • 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.

    PMID: 15201473BACKGROUND

  • 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.

    PMID: 18047458BACKGROUND

  • 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.

    PMID: 9242860BACKGROUND

  • 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.

    PMID: 15838530BACKGROUND

  • 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.

    PMID: 18047660BACKGROUND

  • 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.

    PMID: 15520985BACKGROUND

  • 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.

    PMID: 14682551BACKGROUND

  • 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.

    PMID: 18554816BACKGROUND

  • 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.

    PMID: 18542094BACKGROUND

  • 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.

    PMID: 17132119BACKGROUND

  • 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.

    PMID: 12124669BACKGROUND

  • 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.

    PMID: 19194671BACKGROUND

Study Officials

  • Marc E Duerden, MD

    Rehabilitation Associates of Indiana

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(1)