Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis

NCT00893776 | Terminated

• 1 other identifier: 1134397
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

A small, pilot study consisting of twelve participants with subacute (6-12 months post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The twelve participants will randomly be selected to participate in either unilateral (one-handed) task training (6 participants) or bilateral (two-handed) task training (6 participants) with the SaeboFlex orthosis. Each group will undergo six assessments to establish pre-testing baseline and qualification, followed by a training session, four-week combined home and clinic program, and post-testing to determine changes in affected arm use and function. The hypothesis is that two-handed training will before effective than one-handed training.

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test (WMFT)

  Before and immediately after intervention

Secondary Outcomes (1)

• Canadian Occupational Performance Measure

  Before and immediately after intervention

Study Arms (2)

1 Unilateral Group

ACTIVE COMPARATOR

This group will wear the SaeboFlex orthosis on their affected extremity and do exercises with that extremity only. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns)

Other: Task Training

2 Bilateral training

EXPERIMENTAL

Members of this group will wear the SaeboFlex orthosis on the affected extremity and do exercises with the affected extremity and the non-affected extremity at the same time. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns)

Other: Task Training

Interventions

Task Training OTHER

Task training is the movement of balls in an individually prescribed fashion using the SaeboFlex orthosis on the affected extremity.

1 Unilateral Group; 2 Bilateral training

Eligibility Criteria

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

You may qualify if:

• at least 18 years of age
• \>6 months post stroke
• diagnosis of first stroke
• medically stable
• ability to follow multipart verbal directions
• score of \>26 on Mini-Mental Status Exam
• achieve 10 degrees elbow flexion
• /4 range volitional finger flexion when hand positioned in wrist and finger extension
• capable of standing for \>2 minutes without an assistive ambulatory device
• maintain independence in self-care or have a caretaker to provide assistance
• no concurrent skilled therapy treatment
• not participating in any experimental rehabilitation or drug studies.

You may not qualify if:

• more than one stroke/multiple strokes
• receptive aphasia
• medically documented dementia
• score less than 26 on Mini Mental Status Exam
• contractures or joint deformities in the affected hand or wrist that impede the ability to use the device
• inability to transfer 12 balls crate right and 12 balls crate left, while using the Saeboflex device on the affected arm, by the end of a 5-day training session.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri, Lewis and Clark Hall

Columbia, Missouri, 65211, United States

Location

Related Links

• This is the device we are using for the study.

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giulianne Krug, MA, OTR/L

  University of Missouri, Occupational Therapy and Occupational Science

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)