N/A N=64 Randomized Single-blind Supportive Care

Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02703532 ↗

Enrolled (actual)

Serious AEs

1.6%

Results posted

Jan 2020

Primary outcome: Primary: Wolf Motor Function Test (WMFT) — 12.83; 9.38; 9.73; 4.70 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CARE-CITE Education Program (Behavioral); Traditional Education (Behavioral); Constraint-Induced Movement Therapy (CIMT) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Wolf Motor Function Test (WMFT)	12.83; 9.38; 9.73; 4.70; 8.00; 5.18	—
PRIMARY Motor Activity Log (MAL) Score	2.18; 2.34; 3.33; 3.59; 3.29; 3.39	—
PRIMARY Family Caregiver Conflict Scale (FCCS) Score	28.52; 20.00; 26.95; 21.87; 23.12; 18.57	—
PRIMARY Center for Epidemiologic Studies Depression Scale (CES-D) Score	8.33; 11.64; 8.14; 11.64; 7.84; 9.86	—
SECONDARY Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score	6.36; 6.06; 6.39; 6.48; 6.54; 6.21	—
SECONDARY Fugl-Meyer Assessment (FMA) Score	46.48; 49.91; 52.24; 53.36; 52.99; 55.46	—
SECONDARY Confidence in Arm and Hand (CAHM) Scale Score	58.45; 50.45; 74.12; 70.58; 76.76; 74.05	—
SECONDARY Stroke Impact Scale (SIS) Score	58.33; 51.14; 66.31; 70.17; 84.01; 84.42	—
SECONDARY Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score	12.76; 21.91; 11.52; 16.63; 10.89; 14.03	—
SECONDARY Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score	6.05; 6.21; 6.15; 6.27; 6.13; 6.15	—
SECONDARY Piper Fatigue Scale (PFS) Score	3.82; 3.31; 2.69; 2.58; 2.97; 2.34	—
SECONDARY Caregiver Strain Index (CSI) Score	5.52; 4.82; 5.00; 4.01; 3.78; 4.01	—
SECONDARY Bakas Caregiving Outcomes Scale (BCOS) Score	57.09; 55.91; 62.71; 59.56; 61.62; 60.62	—
SECONDARY Caregiving Self Efficacy (Obtaining Respite Scale) Score	66.44; 68.27; 69.52; 84.50; 71.80; 87.95	—
SECONDARY Post Study System Usability Questionnaire (PSSUQ) Score	1.48	—

Summary

The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.

Eligibility Criteria

Inclusion Criteria

Stroke Survivors

One month to five years post ischemic or hemorrhagic event
Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
Mini-mental screening test score of greater than 24
Presence of a care partner

Caregivers

At least 18 years old
Ability to read and write English
Mini-mental screening test score of greater than 24

Exclusion Criteria

Stroke Survivors

Severe cognitive deficits

Caregivers

Significant cognitive deficits

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02703532). 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.