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

Primary Purpose

Poststroke/CVA Hemiparesis

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
UFT
LFT
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Poststroke/CVA Hemiparesis focused on measuring intensity, rehabilitation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • WanFang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

enhanced upper-extremity program, EUEP

enhanced lower-extremity program,ELLP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Action Research Arm Test (ARAT)
A test that measures the upper extremity motor functions after the stroke.
Berg Balance Test
A test that measures the balance functions.
Fugl-Meyer Assessment (lower extremity subscale)
The FMA-LE (0-34) measures the lower extremity motor functions after the stroke.
Fugl-Meyer Assessment (upper extremity subscale)
FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions.
Time required for 10 meter walking
measuring the walking speed over a 10-meter distance
Stroke Impact Scale
A measure for stroke-specific quality of life
Barthel Index
to measure the activity of daily living

Full Information

First Posted
July 20, 2017
Last Updated
September 30, 2019
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03230370
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No adequate funding
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
May 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poststroke/CVA Hemiparesis
Keywords
intensity, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enhanced upper-extremity program, EUEP
Arm Type
Experimental
Arm Description
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.
Arm Title
enhanced lower-extremity program,ELLP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
UFT
Intervention Description
The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
Intervention Type
Other
Intervention Name(s)
LFT
Intervention Description
The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (upper extremity subscale)
Description
The primary outcome is the change from baseline upper extremity subscale of Fugl-Meyer assessment at the end to 4-wk (post-intervention).
Time Frame
0-, 4- week
Secondary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
A test that measures the upper extremity motor functions after the stroke.
Time Frame
0-, 4-, 8-, 12-, 24 week
Title
Berg Balance Test
Description
A test that measures the balance functions.
Time Frame
0-, 4-, 8-, 12-, 24 week
Title
Fugl-Meyer Assessment (lower extremity subscale)
Description
The FMA-LE (0-34) measures the lower extremity motor functions after the stroke.
Time Frame
0-, 4-, 8-, 12-, 24 week
Title
Fugl-Meyer Assessment (upper extremity subscale)
Description
FMA-UE (0-66), the subscale of FMA that measures the poststroke neuro-motor functions.
Time Frame
0-, 4-, 8-, 12-, 24 week
Title
Time required for 10 meter walking
Description
measuring the walking speed over a 10-meter distance
Time Frame
0-, 4-, 8-, 12-, 24 week
Title
Stroke Impact Scale
Description
A measure for stroke-specific quality of life
Time Frame
0-, 4-, 8-, 12-, 24 week
Title
Barthel Index
Description
to measure the activity of daily living
Time Frame
0-, 4-, 8-, 12-, 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
WanFang Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34695300
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.
Results Reference
derived

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

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