Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.

NCT02693834 | Completed Results

• 1 other identifier: 18863
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine whether one week of practice significantly changes gait outcomes with either of the AFO conditions. INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity, diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in hemiparesis with foot drop will be recruited for this study. EXCLUSION CRITERIA:

1. 1.Not able to receive a double adjustable AFO through their insurance
2. 2.Unable to follow two steps commands
3. 3.Unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance.
4. 4.Cerebellar Stroke
5. 5.Inability to ambulate prior to stroke
6. 6.receiving chemotherapy at the time of study
7. 7.Six Minute walk test
8. 8.Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and fast paced velocity walk.

Conditions

Stroke; CVA; Hemiplegia; Hemiparesis; Foot Drop

Keywords

foot drop; Subacute stroke; AFO; gait symmetry; Gait endurance

Outcome Measures

Primary Outcomes (2)

• Gait Endurance

  6 Minute Walk test (6MWT) to assess gait endurance using DA AFO and PLS AFO

  at baseline

• Gait Endurance

  6MWT to assess gait endurance

  1 week of practice with DA AFO and with PLS AFO randomly

Secondary Outcomes (2)

• Gait Symmetry

  at baseline,1 week with DA AFO, 1 week with PLS AFO

• Gait Velocity SSV and FPV

  at baseline,1 week with DA AFO, 1 week with PLS AFO

Study Arms (2)

PLS AFO first then DA AFO

EXPERIMENTAL

Participants will be assigned to practice with Posterior Leaf spring AFO for a week, then they will be assigned to practice with Double adjustable AFO for another week.

Device: Posterior Leaf spring AFO; Device: Double adjustable AFO

DA AFO first then PLS AFO

EXPERIMENTAL

Participants will be assigned to practice with Double adjustable AFO for a week, then they will be assigned to practice with Posterior Leaf spring AFO for another week

Device: Posterior Leaf spring AFO; Device: Double adjustable AFO

Interventions

Posterior Leaf spring AFO DEVICE

Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.

DA AFO first then PLS AFO; PLS AFO first then DA AFO

Double adjustable AFO DEVICE

Double adjustable AFO is a custom AFO with double action metal upright joints

DA AFO first then PLS AFO; PLS AFO first then DA AFO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with first time unilateral stroke
• weeks post-stroke onset
• resulting in hemiparesis with foot drop

You may not qualify if:

• Inability to receive a double adjustable AFO through their insurance
• unable to follow two steps commands
• unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance
• diagnosis of cerebellar stroke
• non ambulatory prior to stroke onset

Sponsors & Collaborators

• Texas Woman's University: lead
• Baylor Research Institute: collaborator

Study Sites (1)

Baylor Institute for rehabilitation

Frisco, Texas, 75034, United States

Location

Related Publications (26)

• Bijleveld-Uitman M, van de Port I, Kwakkel G. Is gait speed or walking distance a better predictor for community walking after stroke? J Rehabil Med. 2013 Jun;45(6):535-40. doi: 10.2340/16501977-1147.

  PMID: 23584080 BACKGROUND

• Bourland EL, Neville MA, Pickens ND. Loss, gain, and the reframing of perspectives in long-term stroke survivors: a dynamic experience of quality of life. Top Stroke Rehabil. 2011 Sep-Oct;18(5):437-49. doi: 10.1310/tsr1805-437.

  PMID: 22082695 BACKGROUND

• Carse B, Bowers R, Meadows BC, Rowe P. The immediate effects of fitting and tuning solid ankle-foot orthoses in early stroke rehabilitation. Prosthet Orthot Int. 2015 Dec;39(6):454-62. doi: 10.1177/0309364614538090. Epub 2014 Jun 17.

  PMID: 24938770 BACKGROUND

• Eng JJ, Pang MY, Ashe MC. Balance, falls, and bone health: role of exercise in reducing fracture risk after stroke. J Rehabil Res Dev. 2008;45(2):297-313. doi: 10.1682/jrrd.2007.01.0014.

  PMID: 18566947 BACKGROUND

• de Seze MP, Bonhomme C, Daviet JC, Burguete E, Machat H, Rousseaux M, Mazaux JM. Effect of early compensation of distal motor deficiency by the Chignon ankle-foot orthosis on gait in hemiplegic patients: a randomized pilot study. Clin Rehabil. 2011 Nov;25(11):989-98. doi: 10.1177/0269215511410730. Epub 2011 Jul 12.

  PMID: 21750010 BACKGROUND

• Everaert DG, Stein RB, Abrams GM, Dromerick AW, Francisco GE, Hafner BJ, Huskey TN, Munin MC, Nolan KJ, Kufta CV. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):579-91. doi: 10.1177/1545968313481278. Epub 2013 Apr 4.

  PMID: 23558080 BACKGROUND

• Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.

  PMID: 22215894 BACKGROUND

• GAITRite electronic walkway technical reference, revision L. (2013.). (No. WI-02-15).CIR Systems Inc. (GAITRite technical manual)

  BACKGROUND

• Harris JE, Eng JJ, Marigold DS, Tokuno CD, Louis CL. Relationship of balance and mobility to fall incidence in people with chronic stroke. Phys Ther. 2005 Feb;85(2):150-8.

  PMID: 15679466 BACKGROUND

• Hesse, S. (2003). Rehabilitation of gait after stroke: Evaluation, principles of therapy, novel treatment approaches, and assistive devices. Topics in Geriatric Rehabilitation, 19(2), 109-126.

  BACKGROUND

• Hyun CW, Kim BR, Han EY, Kim SM. Use of an ankle-foot orthosis improves aerobic capacity in subacute hemiparetic stroke patients. PM R. 2015 Mar;7(3):264-9. doi: 10.1016/j.pmrj.2014.08.944. Epub 2014 Aug 16.

  PMID: 25134853 BACKGROUND

• Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.

  PMID: 7811170 BACKGROUND

• Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.

  PMID: 15502272 BACKGROUND

• Levin MF, Kleim JA, Wolf SL. What do motor "recovery" and "compensation" mean in patients following stroke? Neurorehabil Neural Repair. 2009 May;23(4):313-9. doi: 10.1177/1545968308328727. Epub 2008 Dec 31.

  PMID: 19118128 BACKGROUND

• Lord SE, McPherson K, McNaughton HK, Rochester L, Weatherall M. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil. 2004 Feb;85(2):234-9. doi: 10.1016/j.apmr.2003.05.002.

  PMID: 14966707 BACKGROUND

• McCain, K. J., Smith, P. S., & Querry, R. (2012). Ankle-foot orthosis selection to facilitate gait recovery in adults after stroke: A case series. Journal of Prosthetics and Orthotics. 24 (3), 111-121.

  BACKGROUND

• Pound P, Gompertz P, Ebrahim S. A patient-centred study of the consequences of stroke. Clin Rehabil. 1998 Aug;12(4):338-47. doi: 10.1191/026921598677661555.

  PMID: 9744669 BACKGROUND

• Rao N, Chaudhuri G, Hasso D, D'Souza K, Wening J, Carlson C, Aruin AS. Gait assessment during the initial fitting of an ankle foot orthosis in individuals with stroke. Disabil Rehabil Assist Technol. 2008 Jul;3(4):201-7. doi: 10.1080/17483100801973023.

  PMID: 18608442 BACKGROUND

• Rosa MC, Marques A, Demain S, Metcalf CD. Fast gait speed and self-perceived balance as valid predictors and discriminators of independent community walking at 6 months post-stroke--a preliminary study. Disabil Rehabil. 2015;37(2):129-34. doi: 10.3109/09638288.2014.911969. Epub 2014 Apr 23.

  PMID: 24754638 BACKGROUND

• Rosen E, Sunnerhagen KS, Kreuter M. Fear of falling, balance, and gait velocity in patients with stroke. Physiother Theory Pract. 2005 Apr-Jun;21(2):113-20. doi: 10.1080/09593980590922299.

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• Schmid AA, Rittman M. Consequences of poststroke falls: activity limitation, increased dependence, and the development of fear of falling. Am J Occup Ther. 2009 May-Jun;63(3):310-6. doi: 10.5014/ajot.63.3.310.

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• Simons CD, van Asseldonk EH, van der Kooij H, Geurts AC, Buurke JH. Ankle-foot orthoses in stroke: effects on functional balance, weight-bearing asymmetry and the contribution of each lower limb to balance control. Clin Biomech (Bristol). 2009 Nov;24(9):769-75. doi: 10.1016/j.clinbiomech.2009.07.006. Epub 2009 Aug 8.

  PMID: 19665825 BACKGROUND

• Slijper A, Danielsson A, Willen C. Ambulatory Function and Perception of Confidence in Persons with Stroke with a Custom-Made Hinged versus a Standard Ankle Foot Orthosis. Rehabil Res Pract. 2012;2012:206495. doi: 10.1155/2012/206495. Epub 2012 May 17.

  PMID: 22685664 BACKGROUND

• Tyson SF, Sadeghi-Demneh E, Nester CJ. A systematic review and meta-analysis of the effect of an ankle-foot orthosis on gait biomechanics after stroke. Clin Rehabil. 2013 Oct;27(10):879-91. doi: 10.1177/0269215513486497. Epub 2013 Jun 24.

  PMID: 23798747 BACKGROUND

• Tyson SF, Kent RM. Effects of an ankle-foot orthosis on balance and walking after stroke: a systematic review and pooled meta-analysis. Arch Phys Med Rehabil. 2013 Jul;94(7):1377-85. doi: 10.1016/j.apmr.2012.12.025. Epub 2013 Feb 12.

  PMID: 23416220 BACKGROUND

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  PMID: 15900185 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Limitations and Caveats

Limited sample size Use of repeated measures design

Results Point of Contact

• Title: Priya Karakkattil, PT PhD
• Organization: Baylor Institute for Rehabilitation

Pjke7991@gmail.com

469-888-5172

Study Officials

• Priya Karakkattil, MS

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 29, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)