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Altering Activation Patterns Post-stroke

Primary Purpose

Stroke, Muscle Spasticity, Hemiparesis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyproheptadine
Placebo for Cyproheptadine
Active Movement Practice (AMP)
Passive Cyclical Stretching
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring hand, rehabilitation, active movement training, passive cyclical stretching

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3)
  • Single stroke occurring at least 6 months prior to enrollment
  • Spasticity
  • Capacity to provide informed consent

Exclusion Criteria:

  • Excessive pain in paretic upper limb
  • Hemispatial neglect (as assessed by the Behavioral Inattention Test)
  • Apraxia (as assessed by the FABERS battery)
  • Botulinum toxin injection in the upper extremity within the past 6 months
  • Introduction of new anti-spasticity medication within the past 6 months
  • Orthopaedic impairments
  • History of seizure disorder
  • Other major health impairment

Sites / Locations

  • Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Cyproheptadine + AMP

Placebo for Cyproheptadine + Stretching

Cyproheptadine + Stretching

Placebo for Cyproheptadine + AMP

Arm Description

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.

Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment.

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment.

Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.

Outcomes

Primary Outcome Measures

Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.

Secondary Outcome Measures

Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)
Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.

Full Information

First Posted
February 5, 2015
Last Updated
October 16, 2023
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02418949
Brief Title
Altering Activation Patterns Post-stroke
Official Title
Altering Activation Patterns in the Distal Upper Extremity After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.
Detailed Description
In this four arm parallel design you will be randomly assigned to one of 4 groups: Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching. The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor. Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke. During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week. The investigators hypothesize that the group receiving the combined cyproheptadine and active movement therapy will have better outcomes than the groups receiving cyproheptadine or active movement therapy alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Muscle Spasticity, Hemiparesis
Keywords
hand, rehabilitation, active movement training, passive cyclical stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyproheptadine + AMP
Arm Type
Experimental
Arm Description
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Arm Title
Placebo for Cyproheptadine + Stretching
Arm Type
Placebo Comparator
Arm Description
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment.
Arm Title
Cyproheptadine + Stretching
Arm Type
Active Comparator
Arm Description
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment.
Arm Title
Placebo for Cyproheptadine + AMP
Arm Type
Active Comparator
Arm Description
Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.
Intervention Type
Drug
Intervention Name(s)
Cyproheptadine
Other Intervention Name(s)
cyproheptadine hydrochloride USP, cyproheptadine HCl, Periactin
Intervention Description
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Intervention Type
Drug
Intervention Name(s)
Placebo for Cyproheptadine
Other Intervention Name(s)
placebo
Intervention Description
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Intervention Type
Other
Intervention Name(s)
Active Movement Practice (AMP)
Intervention Description
Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
Intervention Type
Other
Intervention Name(s)
Passive Cyclical Stretching
Intervention Description
Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
Primary Outcome Measure Information:
Title
Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
Description
GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.
Time Frame
baseline and 9 weeks (immediately post intervention)
Secondary Outcome Measure Information:
Title
Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)
Description
Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.
Time Frame
baseline and 9 weeks (immediately post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3) Single stroke occurring at least 6 months prior to enrollment Spasticity Capacity to provide informed consent Exclusion Criteria: Excessive pain in paretic upper limb Hemispatial neglect (as assessed by the Behavioral Inattention Test) Apraxia (as assessed by the FABERS battery) Botulinum toxin injection in the upper extremity within the past 6 months Introduction of new anti-spasticity medication within the past 6 months Orthopaedic impairments History of seizure disorder Other major health impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek G Kamper, PhD
Organizational Affiliation
North Carolina State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elliot Roth, MD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22275586
Citation
Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382.
Results Reference
background
PubMed Identifier
19964456
Citation
Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.
Results Reference
background
PubMed Identifier
27214905
Citation
Thielbar KO, Triandafilou KM, Fischer HC, O'Toole JM, Corrigan ML, Ochoa JM, Stoykov ME, Kamper DG. Benefits of Using a Voice and EMG-Driven Actuated Glove to Support Occupational Therapy for Stroke Survivors. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):297-305. doi: 10.1109/TNSRE.2016.2569070. Epub 2016 May 17.
Results Reference
background
PubMed Identifier
36054974
Citation
Kamper D, Barry A, Bansal N, Stoykov ME, Triandafilou K, Vidakovic L, Seo N, Roth E. Use of cyproheptadine hydrochloride (HCl) to reduce neuromuscular hypertonicity in stroke survivors: A Randomized Trial: Reducing Hypertonicity in Stroke. J Stroke Cerebrovasc Dis. 2022 Oct;31(10):106724. doi: 10.1016/j.jstrokecerebrovasdis.2022.106724. Epub 2022 Aug 30.
Results Reference
derived
PubMed Identifier
32113974
Citation
Barry AJ, Triandafilou KM, Stoykov ME, Bansal N, Roth EJ, Kamper DG. Survivors of Chronic Stroke Experience Continued Impairment of Dexterity But Not Strength in the Nonparetic Upper Limb. Arch Phys Med Rehabil. 2020 Jul;101(7):1170-1175. doi: 10.1016/j.apmr.2020.01.018. Epub 2020 Feb 28.
Results Reference
derived

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Altering Activation Patterns Post-stroke

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