Evaluating Gait After Use of The Motus Nova Foot Device for Patients With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Heel strike
研究概览
简要总结
Individuals with hemiplegia commonly demonstrate gait deviations such as difficulties with heel strike at initial contact, foot drop in swing, asymmetrical limb loading, muscle activation, and balance impairments. This study evaluates whether a therapeutic device (Motus Nova Foot; FDA approved) used in the home setting can increase heel strike, decrease limp, improve foot clearance in swing phase, improve quality of active muscle contraction of the affected limb, and improve balance. The Motus Nova Foot moves the ankle/foot and uses guided computer/video activities to encourage active participation while automatically recording device use and duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-20 years.
- •Diagnosis consistent with hemiplegia and gait/balance impairments involving ankle/foot control (e.g., reduced heel strike).
- •Able to ambulate and safely participate in laboratory walking and balance testing.
- •Able to follow instructions and use the Motus Nova Foot system at home with family support as needed.
- •Willingness to refrain from standard clinic-based PT during the study period.
排除标准
- •Skin integrity issues or hypersensitivity preventing safe use of straps/pads.
- •Medical/orthopedic conditions making walking or balance testing unsafe (e.g., unstable seizures, recent surgery, acute injury).
- •Inability to safely use the device as determined during fitting/training.
- •Planned participation in standard clinic-based PT during the study period.
- •Electrical stimulation device to lower extremity within 6 months of study start, or planned use of electrical stimulation to lower extremity during study period.
- •Heart conditions that prevent physical activity.
- •Pregnancy.
研究组 & 干预措施
Impact of Motus Nova Foot on Gait and Balance for Individuals with Hemiplegia
Participants will complete a home-based intervention using the Motus Nova Foot device for approximately 8-10 weeks. The device provides robot-assisted ankle/foot movement and interactive computer-guided therapeutic activities designed to improve ankle range of motion, strength, motor control, and gait mechanics. Participants are instructed to use the device 20-40 minutes per day, 4-5 days per week. Activities include 3-5 guided tasks targeting dorsiflexion, plantarflexion, and functional ankle control, with the device automatically recording usage and duration. Families receive an initial in-lab device fitting and training session, and research staff provide weekly check-ins (virtual or in-person) for troubleshooting and adherence support. After the intervention phase, participants complete an 8-10-week no-treatment carryover period with no device use to assess retention of gains.
干预措施: Motus Nova Foot (Device)
结局指标
主要结局
Heel strike
时间窗: 4 months
Heel strike: number of heel strikes on 10 meter walkway at initial contact during walking - whether the participant makes heel-first contact at the beginning of stance. Collected with 3D motion capture (analyzing kinematics).
Ankle dorsiflexion
时间窗: 4 months
Ankle dorsiflexion during swing phase - average angle in degrees of dorsiflexion achieved while the foot is off the ground during gait on 10 meter walkway. Collected with 3D motion capture (analyzing kinematics).
Gait symmetry
时间窗: 4 months
Gait symmetry / Limp - average angle in degrees of asymmetry or "limp" during walking on 10 meter pathway. Collected with 3D motion capture (analyzing kinematics).
sEMG activation
时间窗: 4 months
Lower-extremity muscle activation patterns during gait (sEMG) on 10 m walkway - timing and amplitude characteristics of muscle activity will be measured in mV. Collected with kinesiologic surface electromyograph (sEMG) during 3D motion capture.
Balance performance
时间窗: 4 months
Balance performance - double- and single-leg stance measures (eyes open/closed and weaker vs. stronger limb), measured in distance of center of pressure under foot (mm). Collected via embedded force plates.
次要结局
- Change across time points(4 months)
- Carryover/retention(4 months)
- Device adherence(4 months)
研究者
Brenna Brandsma
Physical Therapist
MultiCare Health System Research Institute