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

NCT ID: NCT03230370

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-05-20

Brief Summary

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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

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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.

Conditions

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Poststroke/CVA Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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enhanced upper-extremity program, EUEP

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.

Group Type EXPERIMENTAL

UFT

Intervention Type OTHER

The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,

enhanced lower-extremity program,ELLP)

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.

Group Type EXPERIMENTAL

LFT

Intervention Type OTHER

The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.

Interventions

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UFT

The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,

Intervention Type OTHER

LFT

The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yen-Nung Lin

Director of Rehabilitation Department of Taipei Medical University WanFang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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WanFang Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 34695300 (View on PubMed)

Other Identifiers

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N201705071

Identifier Type: -

Identifier Source: org_study_id

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