Using Game-based Exercise to Improve Balance in Cancer Patients

Cancer Clinical Trial

Official title:

Managing Chemotherapy Induced Neuropathy in Cancer Patients Using Game-based Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773329
• Other study ID #: H-38347
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: June 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Chemotherapy Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & 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: 10.115 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fear of falling change from Baseline to 6 weeks	Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire	Baseline and 6 weeks

External Links

•   Baylor College of Medicine - iCAMP
•   obstacle crossing exergame