Poststroke/CVA Hemiparesis
Conditions
Keywords
intensity, rehabilitation
Brief summary
Study purpose This study will explore whether an additional rehabilitation program that focus on either upper or lower extremity training facilitate the recovery in upper or lower extremity. The recovery in both neurological status and motor functions will be explored.
Detailed description
Design A single-blinded (assessor-blinded) randomized controlled trial. Interventions The participants will be randomly assigned into two experiment groups (enhanced upper extremity program; and enhanced lower-extremity program). Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy. The enhanced upper extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity, while the enhanced lower-extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. The participants receive 20-day training over a 4-week period. The additional program is designed to be specific to either upper-extremity or lower-extremity. Accordingly, one group can be used as the control group of the other one.
Interventions
OTHERUFT
The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
OTHERLFT
The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. First-ever stroke with the onset 10-90 days prior to the enrollment 2. Age: 20-80y 3. With a hemiplegic upper extremity with Brunnstrom stage in I\ IV 4. Able to understand simple orders (1-step orders, such as raise your hand, touch your head….) 5. Totally independent in activity of daily life before the onset of stroke
Exclusion criteria
1. Incompliance to the assessments or interventions due to unstable medical condition, abnormal cognition, or other conditions. 2. Stroke of brainstem or cerebellum 3. Had received craniotomy or ventriculoperitoneal shunting 4. Needs of orthoses in walking before the onset of stroke 5. Had had motor dysfunctions (eg, amputation, cerebral palsy, poliomyelitis or other neuromuscular diseases) before the stroke. 6. Intracranial hemorrhage caused by artereovenous malformation, aneurysm, or tumor 7. Able to walk independently for more than 50 meters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (upper extremity subscale) | 0-, 4- week | The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Test | 0-, 4-, 8-, 12-, 24 week | A test that measures the balance functions. |
| Fugl-Meyer Assessment (lower extremity subscale) | 0-, 4-, 8-, 12-, 24 week | The FMA-LE (0-34) measures the lower extremity motor functions after the stroke. |
| Fugl-Meyer Assessment (upper extremity subscale) | 0-, 4-, 8-, 12-, 24 week | FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions. |
| Action Research Arm Test (ARAT) | 0-, 4-, 8-, 12-, 24 week | A test that measures the upper extremity motor functions after the stroke. |
| Stroke Impact Scale | 0-, 4-, 8-, 12-, 24 week | A measure for stroke-specific quality of life |
| Barthel Index | 0-, 4-, 8-, 12-, 24 week | to measure the activity of daily living |
| Time required for 10 meter walking | 0-, 4-, 8-, 12-, 24 week | measuring the walking speed over a 10-meter distance |
Countries
Taiwan
Outcome results
None listed