Augmenting Balance in Individuals With Cerebellar Ataxias

NCT ID: NCT02887703

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-01-31

Brief Summary

This study evaluates the effectiveness of a 12-week in home balance training program with and without sensory augmentation for individuals with ataxia. Subjects wear a belt while performing balance exercises three times per week for 12 weeks. The belt measures body motion and has small vibrating elements called tactors mounted inside that when turned on, feel like a cell phone set to vibrate. The tactors provide information about body motion and indicate when and how to make a postural correction. Subjects will receive six weeks of balance training with the tactors turned on and six weeks of balance training with the tactors turned off.

Detailed Description

Cerebellar ataxias are a group of degenerative neurological disorders, resulting in deficits in speech, limb control, balance, and gait. Individuals with degenerative cerebellar ataxias are at a high-risk of falling and have progressive impairments in motor coordination resulting in unsteadiness in gait and posture. No definitive treatment options are available for ataxia. There is therefore a critical need to identify strategies to improve motor function and reduce falls in patients with ataxia. Physical therapy has been demonstrated to improve motor function in subjects with cerebellar ataxia, but the gains in performance following balance training are modest. Sensory augmentation is a technique of augmenting or replacing compromised sensory information. In the context of sensory-based balance impairments, a sensory augmentation device provides cues of body motion that supplement an individual's remaining intact sensory systems. The investigators hypothesize that sensory augmentation may improve the effectiveness of balance training in individuals with ataxia, and aid in greater improvement in motor function than traditional physical therapy alone. Sensory augmentation has been shown to decrease body sway during real-time operation in a laboratory setting in individuals with vestibular deficits and peripheral neuropathy, and general age-related declines in balance performance. Preliminary results suggest that persistent improvements in balance performance exist over time periods of hours to days following a small number of training sessions. This study aims to characterize the effects of sensory augmentation in individuals with ataxia during static and dynamic balance exercises over a period of twelve weeks of in home balance training with and without vibrotactile sensory augmentation.

Conditions

Cerebellar Ataxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sensory Augmentation Group 1

Each subject in Group 1 will undergo 6 weeks of balance training with sensory augmentation followed by 6 weeks of balance training without sensory augmentation.

Group Type: EXPERIMENTAL

Sensory Augmentation

Intervention Type: BEHAVIORAL

Sensory augmentation is a technique of augmenting or replacing compromised sensory information. In the context of sensory-based balance impairments, a sensory augmentation device provides cues of body motion that supplement an individual's remaining intact sensory systems.

Sensory Augmentation Group 2

Each subject in Group 2 will undergo 6 weeks of balance training without sensory augmentation followed by 6 weeks of balance training with sensory augmentation.

Group Type: EXPERIMENTAL

Sensory Augmentation

Intervention Type: BEHAVIORAL

Sensory augmentation is a technique of augmenting or replacing compromised sensory information. In the context of sensory-based balance impairments, a sensory augmentation device provides cues of body motion that supplement an individual's remaining intact sensory systems.

Interventions

Sensory Augmentation

Sensory augmentation is a technique of augmenting or replacing compromised sensory information. In the context of sensory-based balance impairments, a sensory augmentation device provides cues of body motion that supplement an individual's remaining intact sensory systems.

Intervention Type: BEHAVIORAL

Other Intervention Names

vibrotactile biofeedback; haptic feedback

Eligibility Criteria

Inclusion Criteria

• Report to be in good general health
• Are able to read and comprehend English
• Have been diagnosed with either an inherited or sporadic degenerative cerebellar or sensory ataxia
• Are able to stand for at least 30 seconds with no support
• Must be willing and able to comply with study schedule
• Must have wireless internet (WiFi) enabled in their home
• Must be able to perform the home based exercises safely (as assessed by clinical research staff)

Exclusion Criteria

• Are pregnant or believe subject might be pregnant
• Have been diagnosed with arthritis or other musculoskeletal disorder affecting joints, muscles, ligaments and/or nerves that affects the way subject moves
• Have a history of fainting
• Have a severe vision or hearing impairment that is not corrected by glasses or hearing aids
• Have sustained a fall in the last six months that resulted in hospitalization or serious injury
• Have corrected vision worse than 20/70 (considered threshold for moderate visual impairment)
• Are unable to feel the vibrotactile feedback on their torso through the standard t-shirt provided by the study team
• Have ankle dorsi-flexor/plantar-flexor weakness as demonstrated < 4/5 on manual muscle test
• Have limited ankle range of motion demonstrated by inability to dorsiflex to neutral with the knee extended
• Report lower extremity fracture/sprain in the past six months or more than one lower extremity total joint replacement
• Are medically unstable (e.g. chest pain upon exertion, dyspnea, infection)
• Have a history of any other neurological disease besides ataxia that might affect balance (e.g. cerebral vascular accident, Parkinson's disease, MS, ataxia)
• Have a body mass index (BMI) over 30 kg/m2, computed from subject height and weight

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathleen Sienko

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Sienko

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathleen H Sienko, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Mechanical Engineering

Locations

Department of Mechanical Engineering, University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00116756

Identifier Type: -

Identifier Source: org_study_id