The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

Completed

Phase N/A Results N/A

Trial Description

In literature review, thermal stimulation (TS) intervention is effective in facilitating upper extremity functional recovery in stroke patients. In addition, several functional MRI studies have indicated that thermal stimuli promoted activation in the premotor and motor cortices of healthy participants. These imply the possibility of TS in cortical reorganization. However, there were no studies exploring the relationship of the TS intervention and cortical reorganization. By the functional recovery of stroke patients, findings of brain image and brain mapping, it could enhance the understanding the TS influences on brain reorganization. Regarding with clinical application of the TS intervention for improving functional performance of upper extremity in participants with stroke, the best parameters of TS intervention in clinical practice have not been decided. Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute, chronic) undergoing TS intervention with different parameters. Functional scales, kinematic data, brain image were taken in several timelines as outcome measures.

Detailed Description

The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.
There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).

Conditions

Interventions

  • Thermal stimulation system Device
    Other Names: FIRSTEK; Model-B401L, B-300 (local company customized)
    Intervention Desc: One group accept 60 minutes noxious TS and another accept 30 minutes noxious TS in study C.
    ARM 1: Kind: Experimental
    Label: Temperature
    Description: Two research hypotheses will be addressed: 1) Acute stroke patients receiving TS noxious program(Hot/cold pad temperature: 48/4 degrees centigrade.) 5 days per week for the paretic UE will show significantly less UE impairment and disability than those patients receiving TS innoxious program(Hot/cold pad temperature: 40/20 degrees centigrade); 2) The group receiving TS noxious program to stimulate the paretic UE will show fewer deficits and demonstrate better dexterity at 6 months post-stroke than those patients receiving TS innoxious program over the paretic UE.
    ARM 2: Kind: Experimental
    Label: Frequency
    Description: Two research hypotheses will be addressed: 1) Subacute stroke patients receiving either 2 days per week for 6 consecutive weeks or 5 days per week for 6 consecutive weeks with the TS program on the paretic UE will show significantly less UE impairment and disability after 6 weeks than those patients treated with conventional training; 2) The experimental group receiving the TS program of 5 days per week for 6 consecutive weeks will show the fewer UE deficits and better outcomes in terms of dexterity at 12 months post-stroke than those patients receiving TS of 2 days per week for 6 consecutive weeks.
    ARM 3: Kind: Experimental
    Label: Intensity
    Description: Two research hypotheses will be addressed: 1) Chronic stroke patients receiving TS on the paretic UE for either 60 minutes or 30 minutes per day, 5 days per week, for 6 consecutive weeks will show significantly less UE impairment and disability after 6 weeks than those patients treated with conventional training; 2) The experimental group receiving the TS program of 60 minutes per day will show fewer UE deficits and better dexterity at follow-up than those patients receiving TS for 30 minutes per day.
    ARM 4: Kind: Experimental
    Label: High intensity of noxious TS
    Description: High intensity (60 minutes) by noxious thermal stimulation in study C.
    ARM 5: Kind: Experimental
    Label: Low intensity of noxious TS
    Description: Low intensity (30 minutes) of noxious thermal stimulation applying in study C.
  • Thermal stimulation (TS) Device
    Other Names: FIRSTEK; Model-B401L, B-300 (local company customized)
    Intervention Desc: One group accepts heat and cold applying alternately while another group warm and cool applying in study A.
    ARM 1: Kind: Experimental
    Label: Noxious TS
    Description: Accepting heat and cold alternatively applying in study A.
    ARM 2: Kind: Experimental
    Label: Innocuous TS
    Description: Accepting warm and cool alternatively applying in study A.
  • Noxious thermal stimulation Device
    Other Names: FIRSTEK; Model-B401L, B-300 (local company customized)
    Intervention Desc: Using the Noxious thermal stimulation system. One group is 5 days/week while another is 3 days/week in study B.
    ARM 1: Kind: Experimental
    Label: High frequency noxious TS
    Description: 5 days/week in in study B.
    ARM 2: Kind: Experimental
    Label: Low frequency noxious TS
    Description: 3 days/week in study B.
  • Noxious TS Other
    Intervention Desc: hot, cold alternately, noxious TS in study A
    ARM 1: Kind: Experimental
    Label: Noxious TS in study A
    Description: Noxious TS in study A
  • Innocuous TS Other
    Intervention Desc: warm, cool alternately, Innocuious TS in study A
    ARM 1: Kind: Experimental
    Label: Innocuous TS
    Description: Innocuous TS in study A
  • High Frequency of Noxious TS Other
    Intervention Desc: High Frequency of Noxious TS in study B
    ARM 1: Kind: Experimental
    Label: High Frequency of Noxious TS
    Description: High Frequency of Noxious TS in study B
  • Low Frequency of Noxious TS Other
    Intervention Desc: Low Frequency of Noxious TS in study B
    ARM 1: Kind: Experimental
    Label: Low Frequency of Noxious TS
    Description: Low Frequency of Noxious TS in study B
  • High Intensity of Noxious TS Other
    Intervention Desc: High Intensity of Noxious TS in study C
    ARM 1: Kind: Experimental
    Label: High Intensity of Noxious TS
    Description: High Intensity of Noxious TS in study C
  • Low Intensity of Noxious TS Other
    Intervention Desc: Low Intensity of Noxious TS in study C
    ARM 1: Kind: Experimental
    Label: Low Intensity of Noxious TS
    Description: Low Intensity of Noxious TS in study C

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary quality of upper extremity movements as a measure of upper extremity motor function Change from baseline in UE motor function after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Primary mapping area of cortical excitability as a measure of effect on reorganization and functional motor recovery Change from baseline in cortical reorganization after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Primary immediate anatomical and functional cortical changes as a measure of cortical reorganization Change from baseline in cortical reorganization after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Secondary muscles strength as a measure of upper extremities deficits Change from baseline in UE muscle strength after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Secondary independence to score the ability of a patient to care for himself Change from baseline in self care and mobility activities of daily living after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Secondary quality of patients perform tasks as a measure of ability and motor function Change from baseline in UE motor function after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Secondary changes of the muscle tone as a measure of improvement in nervous system Change from baseline in UE muscle tone after 24-times treatments (6 weeks in average) and 1- and 6- month follow-ups No
Primary Movement performance assessment baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up No
Primary Brain images immediate effects in 3 timeline No
Primary Mapping of brain cortex intermediate effect in four timeline No
Primary Kinematics measure of upper extremity movement four timeline No
Secondary Quality of life baseline, post-intervention, 6 month follow-up No

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