A Novel Walking Cane With Haptic Biofeedback Reduces Degenerative Loading in the Arthritic Knee

NCT03900052 | Completed

• 1 other identifier: RX001926
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

The most commonly prescribed mobility aid, the walking cane, is often underloaded and therefore fails to reduce knee joint loading and provide symptomatic relief for those with knee osteoarthritis. For this study, a novel walking cane with haptic biofeedback was designed to improve cane loading. The purpose of this study was twofold; 1) to determine the effectiveness of a novel walking haptic biofeedback cane to encourage proper cane loading compared with a conventional cane, and 2) to determine whether scale training or haptic feedback influences short term retention of cane loading. It is hypothesized that haptic biofeedback would increase cane loading (H1) and decrease knee loading (peak knee adduction moment (H2) and knee adduction angular impulse (H3)) when compared to naïve cane use.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Knee adduction moment; Knee loading; Walking cane

Outcome Measures

Primary Outcomes (4)

• Knee adduction moment (KAM) (percent body weight x height)

  Calculated during stance phase of each step using inverse kinematics then normalized to body weight and height.

  5 minutes

• Peak knee adduction moment (PKAM) (percent body weight x height)

  calculated as highest KAM

  5 minutes

• Knee adduction angular impulse (KAAI) (percent body weight x height x seconds)

  calculated as the area under the KAM curve.

  5 minutes

• Cane loading (percent body weight)

  normalized by weight and peak cane load per step

  5 minutes

Study Arms (5)

Naïve

NO INTERVENTION

Conventional cane with no instruction given

Scale training

ACTIVE COMPARATOR

Conventional cane, scale training, and instruction on proper cane use

Device: typical cane

Scale recall

ACTIVE COMPARATOR

Conventional cane with no further instruction or practice given

Device: typical cane

Haptics training

EXPERIMENTAL

Haptic biofeedback cane with explanation and training.

Device: Haptic cane

Haptics recall

EXPERIMENTAL

Haptic biofeedback cane with no further instruction or practice given.

Device: Haptic cane

Interventions

Haptic cane DEVICE

• A haptic biofeedback cane was designed and manufactured to measure the user applied axial cane load, compare the load to the targeted 20% BW threshold, and then deliver a vibrotactile feedback in the cane handle when the loading was greater than threshold. The cane data acquisition was temporally synchronized to the motion analysis system and recorded axial cane loads at 100 Hz for later analysis. The haptic biofeedback cane consisted of a conventional bariatric walking cane (Patterson Medical Ltd) with a loadcell (Digi-Key100 LBS. Load Cell) placed inside a 3D printed modular cane foot. A microcontroller (Sparkfun™ Pro Micro), SD disk storage (Sparkfun™ OpenLog), eccentric rotating mass vibration motor (model 306-109, Precision Microdrives Limited), USB communications port, and battery completed the system.

Haptics recall; Haptics training

typical cane DEVICE

Typical training cane loading training

Scale recall; Scale training

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic evidence of tibiofemoral knee OA
• Between 35-80 years
• Stand and/or walk for at least 30 minutes without difficulty
• Have a VA medical record

You may not qualify if:

• Knee joint replacement (\<1 year)
• Lateral OA greater than medial OA
• Inadequate cognitive or language function to consent or participate
• BMI \> 40
• pregnancy

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist Specialist

Model Details: 1: Naïve - Conventional cane with no instruction given. 2A: Scale training - Conventional cane, scale training, and instruction on proper cane use. 2B: Scale recall - Conventional cane with no further instruction or practice given 3A: Haptics training - Haptic biofeedback cane with explanation and training. 3B: Haptics recall - Haptic biofeedback cane with no further instruction or practice given.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 2, 2019
• Study Start: June 25, 2015
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share