Status: Not yet recruiting
IRB Number: 00063739
Specialty: Occupational Therapy
Specific Aim 1: Determine efficacy of MP + RTP as compared to RTP and a home exercise program on affected arm functional limitation. Subjects with chronic stroke will be randomly assigned to receive: (a) MP combined with RTP (MP + RTP); [or] (b) RTP only (RTP). This study design will ascertain the additive effect of MP training to RTP, while also discerning the relative contribution of RTP only since motor learning-based, RTP approaches are frequently used by therapists in clinical environments.[1,2}
Affected arm functional limitation, the primary study outcome, will be measured by the Action Research Arm Test (ARAT), the primary outcome measure. The ARAT will be administered by a blinded rater twice before intervention (PRE-1, PRE-2), and directly after intervention (POST), with POST serving as the primary study endpoint. The primary study hypothesis is that subjects in the MP + RTP group will exhibit significantly larger ARAT score changes than RTP subjects at POST. It is also hypothesized that these changes will be sustained 3 months after treatment (POST-3).
Specific Aim 2: Determine the impact of MP + RTP on affected arm outcomes. The sites will administer the upper extremity portion of the Fugl-Meyer Impairment Test (FM), the Arm Motor Ability Test (AMAT), the Motor Activity Log (MAL), and the Stroke Impact Scale (SIS) to all subjects. When compared to their scores before intervention, it is hypothesized that MP + RTP subjects will exhibit significantly larger FM score changes, significantly larger AMAT score changes, significantly larger score changes on the Amount of Use Scale of the MAL, significantly larger score changes on the Quality of Movement scale of the MAL, and larger SIS score changes, all at POST. These differences will be sustained at POST-3. Exploratory analyses will also examine relationships among affected arm use and motor outcomes.
Specific Aim 3: Determine MP + RTP effects on cortical organization using functional magnetic resonance imaging (fMRI). Both sites will administer fMRI at PRE and POST. Based on preliminary data, it is predicted that activation patterns of subjects participating in the MP + RTP and RTP groups will show increased activation volume within the primary region of interest, the ipsilesional affected arm primary motor cortex area (M1), with larger increases in the MP + RTP group. MP + RTP subjects are also expected to exhibit increased ipsilesional activation patterns in the sensorimotor cortex (SMC) and premotor cortex (PMC). In addition, a voxelwise exploratory analysis will examine which brain areas in the PRE fMRI scan predict subsequent behavioral gains, including a covariate term for treatment group to assess whether predictive value of fMRI differs significantly across treatment groups. The researchers will also compare subject outcomes with how the fMRI task activates brains of healthy, age matched controls.
Principal Investigator: Lorie Richards
Department: OCCUPATIONAL THERAPY
Co Investigator: Jeanette Koski
Co Investigator: Kasey Mitchell