Forearm Rotation Orthosis for Stroke

NCT01987414 | Completed Results

• 1 other identifier: 1309M42881
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm. Hypotheses of this study are:

1. 1.participants who wear the forearm rotation orthosis will demonstrate significantly greater improvement in functional performance and active range of motion of forearm rotators compared to those who do not;
2. 2.all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
3. 3.all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

Conditions

Stroke

Keywords

Stroke; Cardiovascular Accident; Task-oriented approach; Orthosis; occupational therapy

Outcome Measures

Primary Outcomes (6)

• Canadian Occupational Performance Measure (COPM) - Performance

  Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.

  Week 1, 8, and 15

• Canadian Occupational Performance Measure (COPM) - Satisfaction

  Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.

  Week 1, 8, and 15

• Wolf Motor Function Test (WMFT) - Time

  This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. The number of seconds required to complete the task is recorded. If the participant exceeds 120 seconds, no additional time will be added and 120 seconds will be recorded. The total score is calculated as a mean of score (in seconds) from the 15 tasks. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.

  Week 1, 8, and 15

• Wolf Motor Function Test (WMFT) - Function

  This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. Participants are scored on their ease of completing each task. Scores range from 1 to 3, with higher scores representing greater ease of task completion. The total score is mean value of the 15 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.

  Week 1, 8, and 15

• Motor Activity Log (MAL) - Amount of Use

  This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how often they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normally use non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.

  Week 1, 8, and 15

• Motor Activity Log (MAL) - How Well

  This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how well they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normal use of non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.

  Week 1, 8, and 15

Secondary Outcomes (15)

• Goniometric Measurements - Shoulder Flexion

  Week 1, 8, and 15

• Goniometric Measurements - Shoulder Abduction

  Week 1, 8, and 15

• Goniometric Measurements - Elbow Extension

  Week 1, 8, and 15

• Goniometric Measurements - Forearm Pronation

  Week 1, 8, and 15

• Goniometric Measurements - Forearm Supination

  Week 1, 8, and 15

Study Arms (2)

Group A

EXPERIMENTAL

Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)

Behavioral: occupational therapy task-oriented approach; Device: Forearm rotation orthosis

Group B

ACTIVE COMPARATOR

no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)

Behavioral: occupational therapy task-oriented approach; Other: No treatment

Interventions

occupational therapy task-oriented approach BEHAVIORAL

It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.

Also known as: OT task-oriented approach

Group A; Group B

Forearm rotation orthosis DEVICE

The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.

Group A

No treatment OTHER

Participants will maintain their daily routines during the no treatment period.

Also known as: control

Group B

Eligibility Criteria

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

You may qualify if:

• Have a diagnosis of stroke for at least three months
• Be 18 years of age or older
• Have sufficient cognitive function to follow three-step verbal instruction and provide independent consent
• Have appropriate trunk and lower extremity function that does not interfere with performance of the upper extremity
• Have at least minimum voluntary movement in the upper extremity (10 degrees of shoulder flex/ abduction, 10 degrees of elbow flexion/extension)
• Not receive any rehabilitative interventions concurrent with the study

You may not qualify if:

• Severe joint deformities or contractures of the affected upper extremity that limit range of motion required for functional tasks
• Capability of voluntarily extending the wrist and fingers through the full range
• Other rehabilitation interventions concurrent with the study
• Have serious uncontrolled medical problems, such as seizures and visual impairment

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Children's Rehabilitation Building, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (12)

• Braendvik SM, Elvrum AK, Vereijken B, Roeleveld K. Relationship between neuromuscular body functions and upper extremity activity in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e29-34. doi: 10.1111/j.1469-8749.2009.03490.x. Epub 2009 Oct 7.

  PMID: 19811515 BACKGROUND

• O'Dwyer NJ, Ada L, Neilson PD. Spasticity and muscle contracture following stroke. Brain. 1996 Oct;119 ( Pt 5):1737-49. doi: 10.1093/brain/119.5.1737.

  PMID: 8931594 BACKGROUND

• Dunning K, Berberich A, Albers B, Mortellite K, Levine PG, Hill Hermann VA, Page SJ. A four-week, task-specific neuroprosthesis program for a person with no active wrist or finger movement because of chronic stroke. Phys Ther. 2008 Mar;88(3):397-405. doi: 10.2522/ptj.20070087. Epub 2008 Jan 10.

  PMID: 18187493 BACKGROUND

• Page SJ, Levine P, Leonard AC. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2005 Mar;19(1):27-32. doi: 10.1177/1545968304272701.

  PMID: 15673841 BACKGROUND

• Page SJ, Levine P, Leonard A, Szaflarski JP, Kissela BM. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Phys Ther. 2008 Mar;88(3):333-40. doi: 10.2522/ptj.20060029. Epub 2008 Jan 3.

  PMID: 18174447 BACKGROUND

• Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.

  PMID: 16514097 BACKGROUND

• Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. doi: 10.1097/01.phm.0000141130.58285.da.

  PMID: 15448577 BACKGROUND

• Lannin NA, Horsley SA, Herbert R, McCluskey A, Cusick A. Splinting the hand in the functional position after brain impairment: a randomized, controlled trial. Arch Phys Med Rehabil. 2003 Feb;84(2):297-302. doi: 10.1053/apmr.2003.50031.

  PMID: 12601664 BACKGROUND

• Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.

  PMID: 11994754 BACKGROUND

• Gillen G. Upper extremity function and management. In G. Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 218-279). St. Louis: Mosby, 2011.

  BACKGROUND

• Milazzo S, Gillen G. Splinting applications. In G Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 326-349). St. Louis: Mosby, 2011

  BACKGROUND

• Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.

  PMID: 18077218 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Chih-Huang Yu
• Organization: University of Minnesota

yuxxx648@umn.edu

6126262443

Study Officials

• Chih-Huang Yu, MS

  Rehabilitation Science Program at the University of Minnesota

  PRINCIPAL INVESTIGATOR

• Virgil Mathiowetz, PhD

  Program in Occupational Therapy, University of Minnesota

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 19, 2013
• Study Start: August 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)