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Completed

NCT Number: NCT03965403

Upper Extremity Rehabilitation With the BURT Robotic Arm

The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female, age 18-80;
  • Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study
  • Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale);
  • Community dwelling;
  • Able to physically fit in the device.

Exclusion criteria

  • Current participation in rehabilitation program targeting upper extremity function;
  • Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes;
  • Visual impairments not corrected with lenses (visual loss);
  • Aphasia sufficient to limit comprehension and completion of the treatment protocol;
  • No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
  • Increased muscle tone (passive movement is difficult);
  • Previous diagnosis of neurological diseases other than stroke;
  • Other conditions affecting function of the stroke affected upper limb;
  • Individuals who present with the following: open wounds, fragile skin, active infection

Treatment and study plan

Arm motor function retraining with BURT

Device

Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions

Primary outcomes

  1. Changes From Baseline in Fugl-Meyer Upper Extremity Scores

    Time frame: 6 weeks

    Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.

Secondary outcomes

  1. Changes From Baseline in Goal Attainment Scale Scores

    Time frame: 6 weeks

    Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met.

    The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met.

Other outcomes

  1. Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)

    Time frame: 6 weeks

    Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.

  2. Changes From Baseline in Motor Activity Log Scores

    Time frame: 6 weeks

    Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life.

  3. Changes From Baseline in Modified Ashworth Scale Scores

    Time frame: 6 weeks

    Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome.

    Tone at the shoulder and elbow were measured

  4. Changes From Baseline in Articulations Range of Motion

    Time frame: 6 weeks

    Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.

  5. Changes From Baseline in Manual Muscle Testing Scale Scores

    Time frame: 6 weeks

    Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes.

  6. Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)

    Time frame: 6 weeks

    Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test.

    The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 29, 2019
Registry last updated
Feb 19, 2020

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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