Forearm Rotation Orthosis for Stroke

Stroke Clinical Trial

Official title:

Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987414
• Other study ID #: 1309M42881
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and

3. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

Description:

Persons with central nervous system (CNS) dysfunction often have difficulty incorporating their affected limb effectively and efficiently into functional tasks due to muscle weakness and/or spasticity. This may further interfere with their performance of everyday activities and restrict life roles. Traditional rehabilitation interventions emphasize spasticity reduction. However, active movement and muscle strength of forearm supination are found strongly related to motor function, rather than spasticity. In contrast, task-oriented movement training trials have demonstrated promising evidence that persons with CNS dysfunction benefit from the training in improvement of motor function and increase functional use of the affected limb.

Orthotic intervention is one therapeutic option for this population. Most orthotic designs for this population are static, developed for sympton reduction or deformity prevention, and aimed at the wrist and hand. However, its effects on spasticity reduction remain controversial. Given that static orthotics may interfere with functional performance and further develop the learned nonuse of the affected limb, a dynamic or mobilization orthosis would be appropriate for enhancing functional performance. Moreover, an orthosis that assists forearm rotation is speculated to enhance functional performance. This study will 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• occupational therapy task-oriented approach
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.

Device:
• Forearm rotation orthosis
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.

Other:
• No treatment
Participants will maintain their daily routines during the no treatment period.

Locations

Country	Name	City	State
United States	Children's Rehabilitation Building, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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.

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. — View Citation

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

O'Dwyer NJ, Ada L, Neilson PD. Spasticity and muscle contracture following stroke. Brain. 1996 Oct;119 ( Pt 5):1737-49. — View Citation

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. — View Citation

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. — View Citation

Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. Review. — View Citation

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. Epub 2006 Mar 2. — View Citation

Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Goniometric Measurements - Shoulder Flexion	A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. 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	Goniometric Measurements - Shoulder Abduction	A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. 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	Goniometric Measurements - Elbow Extension	A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. 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	Goniometric Measurements - Forearm Pronation	A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. 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	Goniometric Measurements - Forearm Supination	A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. 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	Goniometric Measurements - Wrist Extension	A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. 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	Upper Extremity Strength - Shoulder Flexion	A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Shoulder Abduction	A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Elbow Extension	A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Forearm Pronation	A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Forearm Supination	A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Wrist Extension	A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Grip	A Jamar Dynamometer will be used to measure grip strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Palmar Pinch	A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. 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	Upper Extremity Strength - Lateral Pinch	A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. 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