Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot

NCT02990650 | Completed Phase 1

• 1 other identifier: STU00001977
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Using a randomized controlled research design, compare walking outcomes resulting from gait and balance training with standard physical therapist interaction versus training with the addition of a KineAssist® robotic system that provides for safety and freedom of movement.

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (12)

• Mean time of 10 meter walk test at baseline

  baseline

• Mean time of 10 meter walk test at 3 weeks post baseline

  3 weeks post baseline

• Mean time of 10 meter walk test at 6 weeks at end of training

  6 weeks post baseline

• Mean time of 10 meter walk test at 6 months post training

  6 months post end of training

• Mean time of 6 minute walk test at baseline

  baseline

• Mean time of 6 minute walk test at 3 weeks post baseline

  3 weeks post baseline

• Mean time of 6 minute walk test at 6 weeks post baseline (end of training)

  6 weeks post baseline (end of training)

• Mean time of 6 minute walk test at 6 months post training

  6 months post end of training (7.5 months post baseline)

• Mean Berg Balance Scale score at baseline

  The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  baseline

• Mean Berg Balance Scale score at 3 weeks post baseline

  The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  3 weeks post baseline

• Mean Berg Balance Scale score at 6 weeks post baseline (end of training)

  The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  6 weeks post baseline

• Mean Berg Balance Scale score at 6 months post end of training

  The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  6 months post end of training (7.5 months post baseline)

Study Arms (3)

Standard physical therapist

ACTIVE COMPARATOR

A combination of nine balance training tasks where the physical therapist provides guarding against loss of balance

Behavioral: Balance Task Training with therapist guarding support

standard robotic guarding

EXPERIMENTAL

A combination of nine balance training tasks where the robotic system provides guarding against loss of balance

Behavioral: Balance task training with robotic guarding support

challenge based robotic guarding

EXPERIMENTAL

A combination of nine balance training tasks where the robotic system provides guarding against loss of balance while the participant works at a level greater than their current balance capability

Behavioral: Challneged balance task training with robotic guarding support

Interventions

Balance Task Training with therapist guarding support BEHAVIORAL

Nine balance tasks: 1. long forward step 2. forward reach 3. push forward 4. push backward 5. step over hurdle 6. step up on foam surface 7. step up on solid surface 8. sit-to-stand 9. step onto slippery surface The therapist will provide guarding support

Standard physical therapist

Balance task training with robotic guarding support BEHAVIORAL

Nine balance tasks: 1. long forward step 2. forward reach 3. push forward 4. push backward 5. step over hurdle 6. step up on foam surface 7. step up on solid surface 8. sit-to-stand 9. step onto slippery surface The guarding support will be provided by a robot

standard robotic guarding

Challneged balance task training with robotic guarding support BEHAVIORAL

Nine balance tasks where the subject is challenged to perform at a harder level of difficulty: 1. long forward step 2. forward reach 3. push forward 4. push backward 5. step over hurdle 6. step up on foam surface 7. step up on solid surface 8. sit-to-stand 9. step onto slippery surface The guarding support will be provided by a robot

challenge based robotic guarding

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 6 months post-stroke
• post-stroke hemiparesis
• m/sec or slower walking speed

You may not qualify if:

• musculoskeletal injury
• recent history of cardiac event
• other neurological disease or disorders
• inability to follow three-step commands
• uncontrolled diabetes and/or high blood pressure

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Locomotor Control Lab

Birmingham, Alabama, 35210, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: December 13, 2016
• Study Start: October 1, 2008
• Primary Completion: September 1, 2013
• Last Updated: January 19, 2017

Record last verified: 2016-10

Locations

US (1)