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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: TCTR
Last refreshed on: 4 March 2024
Main ID:  TCTR20170324003
Date of registration: 24/03/2017
Prospective Registration: No
Primary sponsor: primary investigator
Public title: Thermotherapy combined with therapeutic exercise improves muscle strength and depression in patients with ischemic stroke
Scientific title: Thermotherapy combined with therapeutic exercise improves muscle strength and depression in patients with ischemic stroke: A Quasi-experimental Study
Date of first enrolment: 04/02/2015
Target sample size:
Recruitment status: Completed
URL:  https://www.thaiclinicaltrials.org/show/TCTR20170324003
Study type:  Interventional
Study design:  Non-randomized  
Phase:  N/A
Countries of recruitment
indonesia
Contacts
Name: yovita dwi   setiyowati
Address:  salemba raya No.41 10440 Jakarta indonesia
Telephone: + 6221 390441
Email: yovitads@gmail.com
Affiliation:  Unaffiliated
Name: yovita dwi   setiyowati
Address:  salemba raya No.41 10440 Jakarta indonesia
Telephone: + 6221 390441
Email: yovitads@gmail.com
Affiliation:  Unaffiliated
Key inclusion & exclusion criteria
Inclusion criteria: (1) first or second onset ischemic stroke;
(2) hemiplegia of the upper or lower limb for less than three months; (3) stable vital signs and no complaint of chest pain for 24 hours; and
(4) a muscle manual testing (MMT) score of < 4.

Exclusion criteria: patients with an episode of trans-ischemic attack (TIA), loss of consciousness, or a previous diagnosis of depression.

Age minimum: 0 N/A (No limit)
Age maximum: 0 N/A (No limit)
Gender: Both
Health Condition(s) or Problem(s) studied
ischemic stroke patients
Intervention(s)
Thermotherapy using hot water pack combined with therapeutic exercise
Experimental Other
The interventional group received combining intervention was thermotherapy using hot water pack and therapeutic exercise then.
The intervention protocol was: The primary researcher trained primary caregivers on how to perform the intervention each day until they could perform it independently and each participant given the guidebook for intervention protocol contain therapeutic exercise guidelines. The patients first applied hot water packs on both their shoulders (deltoid muscle) and knees (hamstring muscle) at a temperature of 41°C for 10 minutes. A thermometer was used to measure the water temperature before the hot water packs were applied, and towels were used to cover the packs. The patients then performed therapeutic exercise for their upper and lower limbs based on the “HOPE: a stroke recovery guide” consisting of program I exercises for the upper limbs (exercise 1: raising the shoulder; exercise 2: strengthening the shoulder; exercise 3: bending the elbow; exercise 4: pulling the shoulder; and exercise 5: shoulder diagonal movement). The lower limb exercises included exercise 1: bending the knee; exercise 2: hip rotation; exercise 3: lifting the knee; exercise 4: cross bending of the knee; and exercise 5: raising the hips.
Primary Outcome(s)
the Changes in muscle strength and depression over time weekly follow-up for 4 weeks Muscle Manual Testing and Aphasic depression rating scale
Secondary Outcome(s)
associations between demographics, muscle strength and depression before and after having completed 4 weeks of intervention demographics questionnaire, Muscle Manual Testing and Aphasic depression rating scale
Secondary ID(s)
Source(s) of Monetary Support
No source of monetary support
Secondary Sponsor(s)
sint carolus school of heatlh sciences
Ethics review
Status: Submitted, approved
Approval date:
Contact:
sesban@litbang.depkes.go.id
Research Ethics Committee of the Ministry of Health, Indonesia
+6221 4261088 Ext.
sesban@litbang.depkes.go.id
Results
Results available:
Date Posted:
Date Completed: 05/02/2015
URL:
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