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

Not Applicable

Withdrawn

• Conditions: Poststroke/CVA Hemiparesis
• Interventions: Other: UFT; Other: LFT

• Registration Number: NCT03230370
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-26
• Study Start: 2018-12-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-03
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
enhanced upper-extremity program, EUEP	UFT	Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy. The EUP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity. The participants receive 20-day training over a 4-weekperiod. 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.
enhanced lower-extremity program,ELLP)	LFT	Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy. The ELP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. The participants receive 20-day training over a4-weekperiod. 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stroke Impact Scale	0-, 4-, 8-, 12-, 24 week	A measure for stroke-specific quality of life
Action Research Arm Test (ARAT)	0-, 4-, 8-, 12-, 24 week	A test that measures the upper extremity motor functions after the stroke.
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.
Time required for 10 meter walking	0-, 4-, 8-, 12-, 24 week	measuring the walking speed over a 10-meter distance
Berg Balance Test	0-, 4-, 8-, 12-, 24 week	A test that measures the balance functions.
Barthel Index	0-, 4-, 8-, 12-, 24 week	to measure the activity of daily living
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.

Trial Locations

Locations (1)

WanFang Hospital; 🇨🇳 New Taipei City, Taiwan