Using Game-based Exercise to Improve Balance in Cancer Patients
Primary Purpose
Chemotherapy Induced Peripheral Neuropathy, Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sensor-based interactive exercise (game-based exercise)
Intervention without game-based exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy Induced Peripheral Neuropathy focused on measuring chemotherapy induced peripheral neuropathy, Cancer, game-based exercise, exercise, wearable sensors, balance, falls, virtual reality
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.
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention with game-based exercise
Intervention without game-based exercise
Arm Description
Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.
Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks
Outcomes
Primary Outcome Measures
Gait Speed change from Baseline to 6 weeks, three months and six months
walking ability is quantified by gait speed.
Balance change from Baseline to 6 weeks, three months and six months
balance is quantified by body sway
Secondary Outcome Measures
Fear of falling change from Baseline to 6 weeks
Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
Full Information
NCT ID
NCT02773329
First Posted
May 9, 2016
Last Updated
June 24, 2019
Sponsor
Baylor College of Medicine
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT02773329
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Peripheral Neuropathy, Cancer
Keywords
chemotherapy induced peripheral neuropathy, Cancer, game-based exercise, exercise, wearable sensors, balance, falls, virtual reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention with game-based exercise
Arm Type
Experimental
Arm Description
Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.
Arm Title
Intervention without game-based exercise
Arm Type
Active Comparator
Arm Description
Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks
Intervention Type
Other
Intervention Name(s)
sensor-based interactive exercise (game-based exercise)
Other Intervention Name(s)
virtual reality exercise
Intervention Description
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 Type
Other
Intervention Name(s)
Intervention without game-based exercise
Other Intervention Name(s)
non-technology based exercise
Intervention Description
Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.
Primary Outcome Measure Information:
Title
Gait Speed change from Baseline to 6 weeks, three months and six months
Description
walking ability is quantified by gait speed.
Time Frame
Baseline, 6 weeks, three months, six months
Title
Balance change from Baseline to 6 weeks, three months and six months
Description
balance is quantified by body sway
Time Frame
Baseline, 6 weeks, three months, six months
Secondary Outcome Measure Information:
Title
Fear of falling change from Baseline to 6 weeks
Description
Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
Citations:
PubMed Identifier
26678611
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.
Results Reference
result
PubMed Identifier
30665876
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.
Results Reference
result
Links:
URL
https://www.youtube.com/watch?v=cYvNI7yfTiA
Description
obstacle crossing exergame
URL
http://www.bcm.edu/icamp
Description
Baylor College of Medicine - iCAMP
Learn more about this trial
Using Game-based Exercise to Improve Balance in Cancer Patients
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