Clinical trial NCT03230370: Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke?
Official title: Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Poststroke/CVA Hemiparesis
Keywords: intensity
rehabilitation
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment (upper extremity subscale)
timeFrame: 0-, 4- week
Secondary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 0-, 4-, 8-, 12-, 24 week
measure: Berg Balance Test
timeFrame: 0-, 4-, 8-, 12-, 24 week
measure: Fugl-Meyer Assessment (lower extremity subscale)
timeFrame: 0-, 4-, 8-, 12-, 24 week
measure: Fugl-Meyer Assessment (upper extremity subscale)
timeFrame: 0-, 4-, 8-, 12-, 24 week
measure: Time required for 10 meter walking
timeFrame: 0-, 4-, 8-, 12-, 24 week
measure: Stroke Impact Scale
timeFrame: 0-, 4-, 8-, 12-, 24 week
measure: Barthel Index
timeFrame: 0-, 4-, 8-, 12-, 24 week
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
References:
citation: Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.