Cancer, Chemotherapy Induced Peripheral Neuropathy
Conditions
Keywords
chemotherapy induced peripheral neuropathy, Cancer, game-based exercise, exercise, wearable sensors, balance, falls, virtual reality
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.
Interventions
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.
OTHERIntervention 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.
Sponsors
National Institutes of Health (NIH)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance change from Baseline to 6 weeks, three months and six months | Baseline, 6 weeks, three months, six months | balance is quantified by body sway |
| Gait Speed change from Baseline to 6 weeks, three months and six months | Baseline, 6 weeks, three months, six months | walking ability is quantified by gait speed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of falling change from Baseline to 6 weeks | Baseline and 6 weeks | Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire |
Countries
United States
Outcome results
None listed