Clinical trial NCT02773329: Using Game-based Exercise to Improve Balance in Cancer Patients
Official title: Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy Induced Peripheral Neuropathy
Cancer
Keywords: chemotherapy induced peripheral neuropathy
Cancer
game-based exercise
exercise
wearable sensors
balance
falls
virtual reality
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Gait Speed change from Baseline to 6 weeks, three months and six months
timeFrame: Baseline, 6 weeks, three months, six months
measure: Balance change from Baseline to 6 weeks, three months and six months
timeFrame: Baseline, 6 weeks, three months, six months
Secondary outcomes:
measure: Fear of falling change from Baseline to 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: 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.
citation: 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.