Cerebrovascular DisordersPhase 2NCT00059696
Treatment for Movement Problems in Elderly Stroke Patients
A Phase 2 study testing Constraint-Induced Movement Therapy in people with Cerebrovascular Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
After a stroke, many patients are left with an impaired arm. Restricting the use of the good arm may improve the use of the bad arm. In "Constraint-Induced Movement" therapy (CI therapy), the good arm is put in a sling to force increased use of the bad arm. The bad arm is also trained each day for several weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disorders
- What is being tested?
- Constraint-Induced Movement Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Nov 2004
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke > 12 months prior to study entry
- Impaired Flexor synergy, pronation and supination of forearm, active wrist extension, active finger extension, and active grasp and release
- Minimum passive range of motion and spasticity criteria (defined as stroke patients who fall into approximately the second to lowest quartile of motor functioning as determined by the Fugl-Meyer Test)
- Available for follow-up at the treatment site (3 years for control patients; 2 years for intervention patients)
Who cannot join
- Folstein Mini-Mental State Examination score < 24
- Token Test of the Multilingual Aphasia Examination score < 36
- Excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities) as determined by study officials
- Serious uncontrolled medical conditions
- Excessive pain in any joint of the affected extremity that could limit ability to cooperate with the intervention, as judged by study officials
- Unable to stand independently for 2 minutes, transfer independently to and from the toilet, or perform sit-to-stand
Show all 10Show fewer
- Current participation in other pharmacological or physical intervention studies
- Injections of anti-spasticity drugs into upper extremity musculature within the past 3 months or wish to have drugs injected in the foreseeable future
- Any oral anti-spasticity drugs at study entry
- Phenol injections within 12 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-1170
About this study
Official title: A Treatment for Excess Motor Disability in the Aged
After a stroke, many patients are left with an impaired arm. Restricting the use of the good arm may improve the use of the bad arm. In "Constraint-Induced Movement" therapy (CI therapy), the good arm is put in a sling to force increased use of the bad arm. The bad arm is also trained each day for several weeks. This study will evaluate the effectiveness of CI therapy in patients with chronic disability after stroke and whether the rate of recovery is decreased in elderly patients.
Read the detailed description
Stroke afflicts over 700,000 Americans each year. Behavioral techniques that impact plasticity of the nervous system need to be incorporated into practical, evidence-based therapeutic interventions. This is especially true at a time when the duration of treatments reimbursed by third party payers has shortened.
CI therapy was derived from basic research with animal subjects and human volunteers. Randomized, controlled studies indicate that it can substantially reduce the motor deficit of patients with mild to moderate chronic strokes and can increase their independence over a period of years. CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb. This gives rise to massed or concentrated repetitive use of the more affected extremity. CI therapy leads to a large increase in use-dependent cortical reorganization involving the recruitment of other regions of the brain in the innervation of the more affected extremity movement.
One of the main aims of the proposed research is to determine if CI therapy can be used with therapeutic success for increasing the amount of real-world extremity use in patients with chronic stroke. Another aim is to ascertain whether the locus of the lesion and its size, as determined by MRI, are factors influencing the extent to which motor function can be recovered through the use of CI therapy.
Eighty patients with chronic stroke will be randomly assigned to receive either CI therapy or a General Fitness control intervention. Two years after study entry, the patients in the control group will be crossed over to receive CI therapy. Primary outcome measures will be a laboratory motor function test and amount of extremity use in the real-world setting. Changes in psychosocial functioning will also be measured.
- Conditions
- Cerebrovascular Disorders
- Being tested
- Constraint-Induced Movement Therapy
- Keywords
- Constraint-Induced Movement Therapy, CI therapy, Rehabilitation, Cerebrovascular accident, Upper extremity, Concentrated, extended practice, Limb restraint, Motor Deficits
- Medical subject headings
- Cerebrovascular Disorders, Stroke, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement TherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2003 (estimated)
- Study startDec 1999
- Primary completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Edward Taub, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059696
- Sponsor's protocol ID
- 2R01HD034273-04
- Status last verified
- May 2011
- First submitted
- 1 May 2003
- Last updated
- 26 Sep 2016
- Results posted
- No
Publications
Taub, E. (1994). Overcoming learned nonuse: A new behavioral medicine approach to physical medicine. In J. G. Carlson, S. R. Seifert, & N. Birbaumer. (eds.) Clinical applied psychophysiology (pp. 185-220). New York: Plenum.
Taub E, Crago JE, Burgio LD, Groomes TE, Cook EW 3rd, DeLuca SC, Miller NE. An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping. J Exp Anal Behav. 1994 Mar;61(2):281-93. doi: 10.1901/jeab.1994.61-281.
PubMed 8169577Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128.
PubMed 27620374Taub E, Crago JE, Uswatte, G: Constraint-Induced Movement Therapy: A new approach to treatment in physical rehabilitation. Rehabilitation Psychology 43: 152-170, 1998.
Miltner WH, Bauder H, Sommer M, Dettmers C, Taub E. Effects of constraint-induced movement therapy on patients with chronic motor deficits after stroke: a replication. Stroke. 1999 Mar;30(3):586-92. doi: 10.1161/01.str.30.3.586.
PubMed 10066856Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51.
PubMed 10659807Kunkel A, Kopp B, Muller G, Villringer K, Villringer A, Taub E, Flor H. Constraint-induced movement therapy for motor recovery in chronic stroke patients. Arch Phys Med Rehabil. 1999 Jun;80(6):624-8. doi: 10.1016/s0003-9993(99)90163-6.
PubMed 10378486Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
PubMed 8466415Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
PubMed 11994754
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment for Excess Motor Disability in the Aged
- ClinicalTrials.gov ID
- NCT00059696
- Acronym / sponsor ID
- 2R01HD034273-04
- Conditions
- Cerebrovascular Disorders
- Keywords
- Constraint-Induced Movement Therapy, CI therapy, Rehabilitation, Cerebrovascular accident, Upper extremity, Concentrated, extended practice, Limb restraint, Motor Deficits
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Dec 1999
- Primary completion
- Nov 2004 (actual)
- First posted
- 5 May 2003 (estimated)
- 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.
After a stroke, many patients are left with an impaired arm. Restricting the use of the good arm may improve the use of the bad arm. In "Constraint-Induced Movement" therapy (CI therapy), the good arm is put in a sling to force increased use of the bad arm. The bad arm is also trained each day for several weeks. This study will evaluate the effectiveness of CI therapy in patients with chronic disability after stroke and whether the rate of recovery is decreased in elderly patients.
Detailed description
Stroke afflicts over 700,000 Americans each year. Behavioral techniques that impact plasticity of the nervous system need to be incorporated into practical, evidence-based therapeutic interventions. This is especially true at a time when the duration of treatments reimbursed by third party payers has shortened.
CI therapy was derived from basic research with animal subjects and human volunteers. Randomized, controlled studies indicate that it can substantially reduce the motor deficit of patients with mild to moderate chronic strokes and can increase their independence over a period of years. CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb. This gives rise to massed or concentrated repetitive use of the more affected extremity. CI therapy leads to a large increase in use-dependent cortical reorganization involving the recruitment of other regions of the brain in the innervation of the more affected extremity movement.
One of the main aims of the proposed research is to determine if CI therapy can be used with therapeutic success for increasing the amount of real-world extremity use in patients with chronic stroke. Another aim is to ascertain whether the locus of the lesion and its size, as determined by MRI, are factors influencing the extent to which motor function can be recovered through the use of CI therapy.
Eighty patients with chronic stroke will be randomly assigned to receive either CI therapy or a General Fitness control intervention. Two years after study entry, the patients in the control group will be crossed over to receive CI therapy. Primary outcome measures will be a laboratory motor function test and amount of extremity use in the real-world setting. Changes in psychosocial functioning will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First stroke > 12 months prior to study entry
- Impaired Flexor synergy, pronation and supination of forearm, active wrist extension, active finger extension, and active grasp and release
- Minimum passive range of motion and spasticity criteria (defined as stroke patients who fall into approximately the second to lowest quartile of motor functioning as determined by the Fugl-Meyer Test)
- Available for follow-up at the treatment site (3 years for control patients; 2 years for intervention patients)
Key exclusion criteria (10 listed)
- Folstein Mini-Mental State Examination score < 24
- Token Test of the Multilingual Aphasia Examination score < 36
- Excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities) as determined by study officials
- Serious uncontrolled medical conditions
- Excessive pain in any joint of the affected extremity that could limit ability to cooperate with the intervention, as judged by study officials
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 |
|---|---|---|
| Constraint-Induced Movement Therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- BackgroundTaub, E. (1994). Overcoming learned nonuse: A new behavioral medicine approach to physical medicine. In J. G. Carlson, S. R. Seifert, & N. Birbaumer. (eds.) Clinical applied psychophysiology (pp. 185-220). New York: Plenum.
- Background: PubMed 8169577Taub E, Crago JE, Burgio LD, Groomes TE, Cook EW 3rd, DeLuca SC, Miller NE. An operant approach to rehabilitation medicine: overcoming learned nonuse by shaping. J Exp Anal Behav. 1994 Mar;61(2):281-93. doi: 10.1901/jeab.1994.61-281.
- Background: PubMed 27620374Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128.
- BackgroundTaub E, Crago JE, Uswatte, G: Constraint-Induced Movement Therapy: A new approach to treatment in physical rehabilitation. Rehabilitation Psychology 43: 152-170, 1998.
- Background: PubMed 10066856Miltner WH, Bauder H, Sommer M, Dettmers C, Taub E. Effects of constraint-induced movement therapy on patients with chronic motor deficits after stroke: a replication. Stroke. 1999 Mar;30(3):586-92. doi: 10.1161/01.str.30.3.586.
- Background: PubMed 10659807Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51.
- Background: PubMed 10378486Kunkel A, Kopp B, Muller G, Villringer K, Villringer A, Taub E, Flor H. Constraint-induced movement therapy for motor recovery in chronic stroke patients. Arch Phys Med Rehabil. 1999 Jun;80(6):624-8. doi: 10.1016/s0003-9993(99)90163-6.
- Background: PubMed 8466415Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
- Background: PubMed 11994754Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
Related trials for Cerebrovascular Disorders
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Edward Taub, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Constraint-Induced Movement Therapy in people with Cerebrovascular Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 26 Sep 2016. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059696, which also lists 9 linked publications.
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 26 Sep 2016.