Clinical trial NCT02803255: AAN Robotic Therapy in SCI
Official title: Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spinal Cord Injuries
Keywords: Injuries
Spinal Cord
Lead sponsor: William Marsh Rice University
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (SCI).


Eligibility criteria: Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.

Inclusion Criteria:

1. Providing written informed consent prior to any study related procedures;
2. Age between 18-75 years;
3. Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
4. Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
5. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
6. Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
7. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;

Exclusion Criteria: Subjects will be excluded if they have:

1. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score \> than 3 out of 4;
2. Subject who cannot provide self-transportation to the study location.

Primary outcomes:
measure: Change in ARAT score
timeFrame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
Secondary outcomes:
measure: Change in Modified Ashworth Scale
timeFrame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
measure: Change in Grip Pinch Strength Assessment
timeFrame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
measure: Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
timeFrame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
measure: Change in Smoothness metrics
timeFrame: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
measure: Change in smoothness metrics
timeFrame: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
Other outcomes:
Locations:
city: Houston
country: United States
facility: Rice University
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: William Marsh Rice University
name: Marcia K. O'Malley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frullo JM, Elinger J, Pehlivan AU, Fitle K, Nedley K, Francisco GE, Sergi F, O'Malley MK. Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial. Front Neurorobot. 2017 Jun 13;11:26. doi: 10.3389/fnbot.2017.00026. eCollection 2017.