Using Game-based Exercise to Improve Balance in Cancer Patients

NCT02773329 | Completed Phase 2

• 1 other identifier: H-38347
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. This study will investigate the acceptability and effect of an interactive motor adaptation balance training program based on wearable sensors for improving balance in older cancer patients with CIPN. Cancer patients with confirmed CIPN will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 6-week balance training program twice per week in either their home or in clinic (based on subject preference) under the supervision of a qualified research staff member. This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month post intervention. Investigators hypothesize that patients receiving sensor-based exercise training will benefit more compared to group receiving conventional non-technology home-based training in terms of improving functional performance and reducing falls.

Conditions

Chemotherapy Induced Peripheral Neuropathy; Cancer

Keywords

chemotherapy induced peripheral neuropathy; Cancer; game-based exercise; exercise; wearable sensors; balance; falls; virtual reality

Outcome Measures

Primary Outcomes (2)

• Gait Speed change from Baseline to 6 weeks, three months and six months

  walking ability is quantified by gait speed.

  Baseline, 6 weeks, three months, six months

• Balance change from Baseline to 6 weeks, three months and six months

  balance is quantified by body sway

  Baseline, 6 weeks, three months, six months

Secondary Outcomes (1)

• Fear of falling change from Baseline to 6 weeks

  Baseline and 6 weeks

Study Arms (2)

Intervention with game-based exercise

EXPERIMENTAL

Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.

Other: sensor-based interactive exercise (game-based exercise)

Intervention without game-based exercise

ACTIVE COMPARATOR

Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks

Other: Intervention without game-based exercise

Interventions

sensor-based interactive exercise (game-based exercise) OTHER

This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action.

Also known as: virtual reality exercise

Intervention with game-based exercise

Intervention without game-based exercise OTHER

Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.

Also known as: non-technology based exercise

Intervention without game-based exercise

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients
• Men or women aged 55 years or older
• Patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons)
• Confirmed peripheral neuropathy (VPT\>25) will be eligible to participate

You may not qualify if:

• Subjects will be excluded if they have undergone surgery in the last 6-8 weeks
• Have Parkinson's Disease
• Stroke patients
• Dementia patients
• Have an active foot ulcer
• Have an active infection
• Lower extremity major amputation
• Patient is taking medications unrelated to cancer treatment that may affect balance and gait
• Patient has other medical conditions that may affect their balance and gait
• Patient is unable to ambulate without assistance.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Schwenk M, Grewal GS, Holloway D, Muchna A, Garland L, Najafi B. Interactive Sensor-Based Balance Training in Older Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2016;62(5):553-63. doi: 10.1159/000442253. Epub 2015 Dec 18.

  PMID: 26678611 RESULT

• Zahiri M, Chen KM, Zhou H, Nguyen H, Workeneh BT, Yellapragada SV, Sada YH, Schwenk M, Najafi B. Using wearables to screen motor performance deterioration because of cancer and chemotherapy-induced peripheral neuropathy (CIPN) in adults - Toward an early diagnosis of CIPN. J Geriatr Oncol. 2019 Nov;10(6):960-967. doi: 10.1016/j.jgo.2019.01.010. Epub 2019 Jan 18.

  PMID: 30665876 RESULT

Related Links

• obstacle crossing exergame

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exergaming; Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 16, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

US (1)