Lower Extremity Motor Dysfunction, Spinal Cord Injury Clinical Trial
— ARTOfficial title:
Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot
| NCT number | NCT03452059 |
| Other study ID # | ART-1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 11, 2017 |
| Est. completion date | January 13, 2018 |
| Verified date | July 2018 |
| Source | AI-Robotics Technology Co., Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 13, 2018 |
| Est. primary completion date | January 13, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: 1. more than18 but less than 60 years old,less than 80 kilos of weight,Gender is not limited 2. Confirmed by MR/CT,AIS spinal cord injury grade: A-C level (without walking ability):Damage plane T6-L2 3. The muscle tension of the modified Ashworth grade level is less than or equal to 2 4. The range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint Neutral position 5. Upper limb strength and physical strength are sufficient to stabilize the crutches 6. Patients are able to understand and actively participate in the training program, agree and sign the informed consent form Exclusion Criteria: 1. The range of motion of the joints is severely limited and the walking action is limited 2. Spinal fractures are not completely healed, the clinical situation is unstable; if not fully confirmed,please go department of orthopedics or other clinical departments for diagnosing 3. Skin injury or infection of the lower extremities or the part of wearing robot 4. Unstable angina, severe arrhythmia and other heart diseases 5. Severe chronic obstructive pulmonary disease 6. Unilateral neglect 7. Severe cognitive or visual impairment 8. Other contraindications or complications that may affect walking training 9. Pregnant or lactating women 10. The investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| AI-Robotics Technology Co., Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Walking efficiency | 6 minute walk distance,measured by meters | 6 minute | |
| Primary | Walking efficiency | average heart increasing rate,measured by times/min | 6 minute | |
| Secondary | Cardiovascular response | heart rate during and after 6 minute walk test | during 6 minute walk test and right before the 6MWT | |
| Secondary | efficiency of put on or take off the Ailegs/Aiwalker/HKAFO | to measure the time of putting on or taking off the Ailegs/Aiwalker/HKAFO before or after 6 min walk test | immediately before beginning (pre-) and immediately after finishing (post-) each of 6 minute walk test | |
| Secondary | RPE questionaire | the RPE is recorded after the 6 min walk test | after 6 minute walk test |