Using Game-based Exercise to Improve Balance in Cancer Patients

Phase 2

Completed

• Conditions: Cancer; Chemotherapy Induced Peripheral Neuropathy
• Interventions: Other: sensor-based interactive exercise (game-based exercise); Other: Intervention without game-based exercise

• Registration Number: NCT02773329
• Lead Sponsor: Baylor College of Medicine

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-16
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with game-based exercise	sensor-based interactive exercise (game-based exercise)	Subjects will be receiving sensor-based interactive exercise program (game-based exercise) intervention twice a week for 6 weeks.
Intervention without game-based exercise	Intervention without game-based exercise	Subjects will be receiving non-technology based foot and ankle exercise twice a week for 6 weeks

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States