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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Poststroke/CVA Hemiparesis
• Intervention / Treatment: Other: UFT; Other: LFT

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: UFT; The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
Experimental: 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.	Other: LFT; The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): May 20, 2020
• Study Completion (Anticipated): May 20, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; intensity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: N201705071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No