Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke?

Poststroke/CVA Hemiparesis Clinical Trial

Official title:

Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03230370
• Other study ID #: N201705071
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 20, 2020

Study information

• Verified date: September 2019
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paresis
• Poststroke/CVA Hemiparesis

Intervention

Other:
• UFT
The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
• LFT
The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (upper extremity subscale)	The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention).	0-, 4- week
Secondary	Action Research Arm Test (ARAT)	A test that measures the upper extremity motor functions after the stroke.	0-, 4-, 8-, 12-, 24 week
Secondary	Berg Balance Test	A test that measures the balance functions.	0-, 4-, 8-, 12-, 24 week
Secondary	Fugl-Meyer Assessment (lower extremity subscale)	The FMA-LE (0-34) measures the lower extremity motor functions after the stroke.	0-, 4-, 8-, 12-, 24 week
Secondary	Fugl-Meyer Assessment (upper extremity subscale)	FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions.	0-, 4-, 8-, 12-, 24 week
Secondary	Time required for 10 meter walking	measuring the walking speed over a 10-meter distance	0-, 4-, 8-, 12-, 24 week
Secondary	Stroke Impact Scale	A measure for stroke-specific quality of life	0-, 4-, 8-, 12-, 24 week
Secondary	Barthel Index	to measure the activity of daily living	0-, 4-, 8-, 12-, 24 week