Using Game-based Exercise to Improve Balance in Cancer Patients

• ClinicalTrials.gov Identifier: NCT02773329
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: June 26, 2019
• Sponsor: Baylor College of Medicine
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Bijan Najafi, PhD, Baylor College of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chemotherapy Induced Peripheral Neuropathy; Cancer	Other: sensor-based interactive exercise (game-based exercise); Other: Intervention without game-based exercise	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: May 2019
• Actual Study Completion Date: May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention with game-based exercise; 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); 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.; Other Name: virtual reality exercise
Active Comparator: Intervention without game-based exercise; Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks	Other: Intervention without game-based exercise; Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.; Other Name: non-technology based exercise

Outcome Measures

Primary Outcome Measures :

1. Gait Speed change from Baseline to 6 weeks, three months and six months [ Time Frame: Baseline, 6 weeks, three months, six months ]
   walking ability is quantified by gait speed.
2. Balance change from Baseline to 6 weeks, three months and six months [ Time Frame: Baseline, 6 weeks, three months, six months ]
   balance is quantified by body sway

Secondary Outcome Measures :

1. Fear of falling change from Baseline to 6 weeks [ Time Frame: Baseline and 6 weeks ]
   Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

National Institutes of Health (NIH)

More Information

Additional Information:

obstacle crossing exergame 

Baylor College of Medicine - iCAMP 

Publications of Results:

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.

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.

• Responsible Party: Bijan Najafi, PhD, Principal Investigator, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02773329
• Other Study ID Numbers: H-38347
• First Posted: May 16, 2016
• Last Update Posted: June 26, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.

Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:

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

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases