Poststroke/CVA HemiparesisNCT03230370
Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke?
A study testing UFT and LFT in people with Poststroke/CVA Hemiparesis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Poststroke/CVA Hemiparesis
- What is being tested?
- UFT and LFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2018to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Poststroke/CVA Hemiparesis
- Being tested
- UFT, LFT
- Keywords
- intensity, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFTOther
The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
LFTOther
The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: LFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0-, 4- week
Secondary outcomes (7)
Action Research Arm Test (ARAT)
A test that measures the upper extremity motor functions after the stroke.
Measured: 0-, 4-, 8-, 12-, 24 week
Berg Balance Test
A test that measures the balance functions.
Measured: 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.
Measured: 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.
Measured: 0-, 4-, 8-, 12-, 24 week
Time required for 10 meter walking
measuring the walking speed over a 10-meter distance
Measured: 0-, 4-, 8-, 12-, 24 week
Stroke Impact Scale
A measure for stroke-specific quality of life
Measured: 0-, 4-, 8-, 12-, 24 week
Barthel Index
to measure the activity of daily living
Measured: 0-, 4-, 8-, 12-, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Dec 2018 (estimated)
- Primary completion20 May 2020 (estimated)
- Study completion20 May 2020 (estimated)
Why it stopped: No adequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poststroke/CVA HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230370
- Sponsor's protocol ID
- N201705071
- Status last verified
- Sep 2019
- First submitted
- 20 Jul 2017
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34695300
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke? A Multicenter Randomized Controlled Study (TIARAS Trial)
- ClinicalTrials.gov ID
- NCT03230370
- Acronym / sponsor ID
- N201705071
- Conditions
- Poststroke/CVA Hemiparesis
- Keywords
- intensity, rehabilitation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No adequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enhanced upper-extremity program, EUEP | Experimental | Other: UFTBoth 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) | Experimental | Other: LFTBoth 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UFTThe EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity, | Other | enhanced upper-extremity program, EUEP |
| LFTThe ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. | Other | enhanced lower-extremity program,ELLP) |
Primary outcome
Fugl-Meyer Assessment (upper extremity subscale)
Time frame: 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).
7 secondary outcomes
Action Research Arm Test (ARAT)
Time frame: 0-, 4-, 8-, 12-, 24 week
Berg Balance Test
Time frame: 0-, 4-, 8-, 12-, 24 week
Fugl-Meyer Assessment (lower extremity subscale)
Time frame: 0-, 4-, 8-, 12-, 24 week
Fugl-Meyer Assessment (upper extremity subscale)
Time frame: 0-, 4-, 8-, 12-, 24 week
Time required for 10 meter walking
Time frame: 0-, 4-, 8-, 12-, 24 week
Stroke Impact Scale
Time frame: 0-, 4-, 8-, 12-, 24 week
Barthel Index
Time frame: 0-, 4-, 8-, 12-, 24 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 34695300Clark 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.
- Individual participant dataSharing planned: No
Related trials for Poststroke/CVA Hemiparesis
Active, not recruiting
Comparative Effects of CIMT and TOT on Hand Function Recovery in Post Stroke Patients
Poststroke/CVA Hemiparesis
Not yet recruiting
Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
Cerebral Palsy, Hemiparesis; Poststroke/CVA
Not yet recruiting
Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
Stroke, Neurological Diseases or Conditions
RecruitingPhase 1
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Stroke, Chronic Stroke
RecruitingPhase 2
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Stroke, Stroke Sequelae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UFT and LFT in people with Poststroke/CVA Hemiparesis, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (upper extremity subscale) (time frame: 0-, 4- week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.