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Completed

NCT Number: NCT02803255

AAN Robotic Therapy in SCI

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rice University, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Providing written informed consent prior to any study related procedures;
  • Age between 18-75 years;
  • 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;
  • Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
  • No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  • Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
  • 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:

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

Treatment and study plan

MAHI Exo-II

Device

Other names: Robot-aided movement therapy

Primary outcomes

  1. Change in ARAT score

    Time frame: 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

  1. Change in Modified Ashworth Scale

    Time frame: 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

  2. Change in Grip Pinch Strength Assessment

    Time frame: 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

  3. Change in Graded Redefined Assessment of Strength, Sensibility and Prehension

    Time frame: 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

  4. Change in Smoothness metrics

    Time frame: 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

    Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed

  5. Change in smoothness metrics

    Time frame: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start

    Measured via analysis of point-to-point reaching movements performed with the robot. Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed

Sponsors and collaborators

Lead sponsor

William Marsh Rice University

Other

Registry information

Official study title

Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2016
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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