Augmenting Balance in Individuals With Cerebellar Ataxias

NCT02887703 | Completed

• 1 other identifier: HUM00116756
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebellar Ataxia

Keywords

ataxia; balance training; vibrotactile biofeedback; sensory augmentation; cerebellar ataxia

Outcome Measures

Primary Outcomes (1)

• Change in Scale for the assessment and rating of ataxia (SARA)

  An 8-item scale including walking, standing, sitting, nose-to-finger movements, and fast alternating movements. Standard assessment scale for determining impairment level in individuals with ataxia.

  pre balance training (week 1), mid balance training (week 6), post balance training (week 12)

Secondary Outcomes (2)

• Change in 10-meter Preferred Gait Speed

  pre balance training (week 1), mid balance training (week 6), post balance training (week 12)

• Change in 10-meter Fast Gait Speed

  pre balance training (week 1), mid balance training (week 6), post balance training (week 12)

Other Outcomes (4)

• Change in Five Times Sit to Stand Test

  pre balance training (week 1), mid balance training (week 6), post balance training (week 12)

• Change in Activities Specific Balance scale (ABC)

  pre balance training (week 1), mid balance training (week 6), post balance training (week 12)

• Change in Berg Balance Score

  pre balance training (week 1), mid balance training (week 6), post balance training (week 12)

Study Arms (2)

Sensory Augmentation Group 1

EXPERIMENTAL

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.

Behavioral: Sensory Augmentation

Sensory Augmentation Group 2

EXPERIMENTAL

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.

Behavioral: Sensory Augmentation

Interventions

Sensory Augmentation 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.

Also known as: vibrotactile biofeedback, haptic feedback

Sensory Augmentation Group 1; Sensory Augmentation Group 2

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathleen Sienko: lead

Study Sites (1)

Department of Mechanical Engineering, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cerebellar Ataxia; Ataxia

Interventions

Haptic Technology

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bioengineering; Engineering; Technology, Industry, and Agriculture; Technology; Man-Machine Systems

Study Officials

• Kathleen H Sienko, Ph.D.

  Department of Mechanical Engineering

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 2, 2016
• Study Start: September 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

US (1)