The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

Stroke Clinical Trial

Official title:

The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418404
• Other study ID #: NHRI-EX99-9907PI
• Status: Completed
• Phase: N/A
• First received: June 26, 2011
• Last updated: April 6, 2015
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. first-ever ischemic stroke;

2. no severe cognitive impairments and able to follow instructions;

3. sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

1. musculoskeletal or cardiac disorders that potentially interferes with experimental tests;

2. diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;

3. speech disorder or global aphasia;

4. skin problems at the sites of stimulation;

6.contraindications of heat or ice application.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Noxious TS
hot, cold alternately, noxious TS in study A
• Innocuous TS
warm, cool alternately, Innocuious TS in study A
• High Frequency of Noxious TS
High Frequency of Noxious TS in study B
• Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
• High Intensity of Noxious TS
High Intensity of Noxious TS in study C
• Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung city

Sponsors (3)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	E-DA Hospital, Kaohsiung Municipal Hsiaokang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement performance assessment	Movement performance assessment by clinical motor assessment scales in upper extremity; executed by qualified physiotherapy; in study A, B, C	baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up	No
Primary	Brain images	"intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day; immediate effects of intervention in the 1st day and 24th of intervention, six-month follow-up; this examination is optional; in study A.; use regular scan examination of hospital and operated by trained qualified professionals, the attending is consulted; This examination can be stopped at any time if participants do not want to perform or feeling unwell	immediate effects in 3 timeline	No
Primary	Mapping of brain cortex	"intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day; immediate effects of intervention in the 1st day and 24th of intervention, one-month follow-up, six-month follow-up; in study A.; this examination is optional; use equipment of brain mapping and operated under trained staff, the attending is consulted This examination can be stopped at any time if participants do not want to perform or feeling unwell	immediate effect in four timeline	No
Primary	Kinematics measure of upper extremity movement	1st day and 24th of intervention, one-month follow-up, six-month follow-up (This examination is optional); signal emission marks are sticked on surface skin during motion tests; this examination is optional; --in study A.; executed by trained qualified physiotherapy	four timeline	No
Secondary	Quality of life	Quality of life by subjective questionnaires; executed by qualified physiotherapy --in study A, B, C.	baseline, post-intervention, 6 month follow-up	No