Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project

NCT03530592 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HP-68734
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.

Conditions

Peripheral Nervous System Diseases; Gait Disorders, Neurologic; Foot Drop; Mobility Limitation

Outcome Measures

Primary Outcomes (6)

• Ankle dorsiflexion-plantarflexion range of motion

  degrees

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Ankle inversion-eversion range of motion

  degrees

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Gait velocity during self-selected overground walking

  cm/sec

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Postural sway areas during quiet standing

  cm\^2; extent of postural deviations to assess static postural control

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Ratio of asymmetric loading in quiet standing

  ratio of Newtons of force per leg while standing quietly

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

• Push-off forces during gait initiation

  Newtons; magnitude of forward ground reaction forces.

  Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training

Study Arms (1)

Seated Ankle Robot Training

EXPERIMENTAL

Device: Seated Ankle Robot Training

Interventions

Seated Ankle Robot Training DEVICE

This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.

Seated Ankle Robot Training

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged 18 to 88 years
• Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
• Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device\[s\] is permitted)

You may not qualify if:

• Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
• Current participation in orthopedic or rehabilitation medical programs
• Active deep venous thrombosis
• Distal paretic leg skin lesions, infections, or soft tissue inflammation

Sponsors & Collaborators

• Baltimore VA Medical Center: lead

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Gait Disorders, Neurologic; Peroneal Neuropathies; Mobility Limitation

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mononeuropathies

Study Officials

• Charlene E. Hafer-Macko, M.D.

  Baltimore VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate C. Flores

CONTACT

(410) 637-3242; kate.flores@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: Seated Ankle Robot Taining

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 21, 2018
• Study Start: June 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)