NCT03230370

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

October 3, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

July 20, 2017

Last Update Submit

September 30, 2019

Conditions

Poststroke/CVA Hemiparesis

Keywords

intensityrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Action Research Arm Test (ARAT)

    0-, 4-, 8-, 12-, 24 week

  • Berg Balance Test

    0-, 4-, 8-, 12-, 24 week

  • Fugl-Meyer Assessment (lower extremity subscale)

    0-, 4-, 8-, 12-, 24 week

  • Fugl-Meyer Assessment (upper extremity subscale)

    0-, 4-, 8-, 12-, 24 week

  • Time required for 10 meter walking

    0-, 4-, 8-, 12-, 24 week

  • +2 more secondary outcomes

Study Arms (2)

enhanced upper-extremity program, EUEP

EXPERIMENTAL

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.

Other: UFT

enhanced lower-extremity program,ELLP)

EXPERIMENTAL

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.

Other: LFT

Interventions

UFTOTHER

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

enhanced upper-extremity program, EUEP
LFTOTHER

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

enhanced lower-extremity program,ELLP)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-ever stroke with the onset 10-90 days prior to the enrollment
  • Age: 20-80y
  • With a hemiplegic upper extremity with Brunnstrom stage in I\~IV
  • Able to understand simple orders (1-step orders, such as "raise your hand, touch your head….)
  • Totally independent in activity of daily life before the onset of stroke

You may not qualify if:

  • Incompliance to the assessments or interventions due to unstable medical condition, abnormal cognition, or other conditions.
  • Stroke of brainstem or cerebellum
  • Had received craniotomy or ventriculoperitoneal shunting
  • Needs of orthoses in walking before the onset of stroke
  • Had had motor dysfunctions (eg, amputation, cerebral palsy, poliomyelitis or other neuromuscular diseases) before the stroke.
  • Intracranial hemorrhage caused by artereovenous malformation, aneurysm, or tumor
  • Able to walk independently for more than 50 meters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Hospital

New Taipei City, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 34695300DERIVED
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Rehabilitation Department of Taipei Medical University WanFang Hospital

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 26, 2017

Study Start

December 1, 2018

Primary Completion

May 20, 2020

Study Completion

May 20, 2020

Last Updated

October 3, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)