Phase 2
N=127
Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00372411 ↗Enrolled (actual)
127
Serious AEs
29.9%
Results posted
Jan 2014
Primary outcome: Primary: Fugl-Meyer Assessment for Motor Recovery (FM) Scale — 3.01; 3.19; -2.08; 3.87 units on a scale — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Robot-Assisted Therapy - MIT-MANUS System (Device); Intensive Comparison Therapy (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment for Motor Recovery (FM) Scale |
3.01; 3.19; -2.08; 3.87; 4.01; -1.06 | 0.08 |
| SECONDARY Stroke Impact Scale |
5.49; 4.08; -3.79; 6.31; 5.77; -3.03 | 0.009 sig |
| SECONDARY Wolf Motor Function Test |
-3.98; -3.24; 7.38; -3.96; -4.89; 7.54 | 0.22 |
| SECONDARY Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline |
-0.61; 0.24; 0 | 0.08 |
| SECONDARY Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline |
-0.07; 0.12; -0.04 | 0.95 |
Summary
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.
Eligibility Criteria
Inclusion Criteria
- A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
- Age 18 years of age and older.
- Upper extremity Fugl-Meyer score >=7 or <=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
- Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
- Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
- Written informed consent to participate in the study.
Exclusion Criteria
- A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
- Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
- Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
- Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
- A complicating medical condition that would prevent completion of the trial.
- Unable to complete the nine-month study, e.g., extended planned vacation.
- Any other known pre-existing bone diseases that might increase the risk of bone fracture or other injury from intensive comparison therapy or robot-assisted therapy.
Data sourced from ClinicalTrials.gov (NCT00372411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.