Treatment for Movement Problems in Elderly Stroke Patients

NCT00059696 | Completed Phase 2

• 1 other identifier: 2R01HD034273-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebrovascular Disorders

Keywords

Constraint-Induced Movement Therapy; CI therapy; Rehabilitation; Cerebrovascular accident; Upper extremity; Concentrated, extended practice; Limb restraint; Motor Deficits

Interventions

Constraint-Induced Movement Therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-1170, United States

Location

Related Publications (9)

• 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.

  BACKGROUND

• 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.

  PMID: 8169577 BACKGROUND

• Taub 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.

  PMID: 27620374 BACKGROUND

• Taub E, Crago JE, Uswatte, G: Constraint-Induced Movement Therapy: A new approach to treatment in physical rehabilitation. Rehabilitation Psychology 43: 152-170, 1998.

  BACKGROUND

• 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.

  PMID: 10066856 BACKGROUND

• Taub 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.

  PMID: 10659807 BACKGROUND

• Kunkel 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.

  PMID: 10378486 BACKGROUND

• Taub 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.

  PMID: 8466415 BACKGROUND

• Taub 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.

  PMID: 11994754 BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke; Neurologic Manifestations

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Edward Taub, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 1, 2003
• First Posted: May 5, 2003
• Study Start: December 1, 1999
• Primary Completion: November 1, 2004
• Last Updated: September 26, 2016

Record last verified: 2011-05

Locations

US (1)