Back to resultsSpiral Strapping for Improving Upper Limb Functions
Primary Purpose
Stroke, Splints, Physical Disability
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
TogRite stretch Strapping
Traditional upper limb functional exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper Limb Functions, Spiral Strapping
Eligibility Criteria
Inclusion Criteria: The inclusion criteria were as follow: Participants were diagnosed as chronic stroke patients. Participants were selected to be in the spastic phase. The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+&2) according to Modified Ashworth Scale. Participants were all between 50 and 60 years old, of both sexes. Participants were cognitively able to understand and follow instructions. Participants had the ability to extend their wrist joints at least 20° and fingers 10° from full flexion. This range allowed participants to engage easily in performing a designed functional program. Exclusion Criteria: The exclusion criteria were as follow: Participants who were with any orthopedic condition or fixed deformity that interfere with the upper limb functions. Participants who were with spasticity of more than score 2 according to the Modified Ashworth Scale. Participants who had cognitive or perceptual problems. Participants with seizures, visual impairments, or auditory problems. Participants who had shoulder pain on a visual analogue scale of > 6/10. Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.
Sites / Locations
- Ehab Mohamed Abd El KafyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Individuals who will participate in the control group will receive a traditional functional exercise training protocol (conventional physiotherapy program) for one hour. It will focus on the enhancement of muscle strength, joint range of motion, arm &hand activities, and daily living functions of the affected upper limbs. The treatment, for the control group, will be conducted over a period of 4 successive weeks, with 3 sessions per week.
Participants in the experimental group will receive the conventional treatment program similar to that will be provided to the control group. The treatment, for the experimental group, will be conducted over a period of 4 successive weeks, with 3 sessions per week. Moreover, they will ¬wear an upper limb spiral strapping system with a hand splint 8 hours daily/ 6 days per week.
Outcomes
Primary Outcome Measures
Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia. It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
Modified Ashworth Scale was used to evaluate the degree of spasticity in the involved upper limb in the elbow and wrist joints. MAS is a valid and a reliable scale to evaluate the degree of muscle tone for all participants pre and post treatment. It is scored on a 6 -graded ordinal scale.
Change in the upper limb' joints range of motion (in degree)
Digital Goniometer was used to evaluate the following joints range of motion (shoulder abduction& external rotation, elbow extension and forearm supination). The Digital Goniometer has used a sensor to calculate the amount of joint range of motion in degrees to measure the true range of motion value.
Secondary Outcome Measures
Change in the Hand Grip Strength of the involved upper extremity (Kg) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
Hand Grip Dynamometer was used to assess the change in the strength of the hand muscles of the involved upper extremity. The higher the score of the hand grip after completion of the treatment program compared to the baseline score, the better the improvement of hand functional abilities.
Full Information
NCT ID
NCT05725941
First Posted
January 23, 2023
Last Updated
February 2, 2023
Sponsor
Umm Al-Qura University
Collaborators
Princess Nourah Bint Abdulrahman University
1. Study Identification
Unique Protocol Identification Number
NCT05725941
Brief Title
Spiral Strapping for Improving Upper Limb Functions
Official Title
The Effectiveness of Spiral Strapping on Upper Limb Functions in Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
March 25, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University
Collaborators
Princess Nourah Bint Abdulrahman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Upper limb recovery after stroke is unacceptably poor with almost half of stroke survivors likely to regain some functional use. The rehabilitation process for upper extremity for individuals with stroke is of long duration and clinicians face the challenge of identifying a variety of assistive appliances that may be adapted and graded to facilitate this process. One of these appliances that is widely used in rehabilitation is splint and strapping. Therefore, this study aims to investigate the effectiveness of this modality in rehabilitation of the upper limb in stroke survivors.
Detailed Description
Stroke often results in spasticity and associated motor impairments in the upper limb Spasticity in the upper limb commonly interferes with its motor activities, and results in impairments in the upper limb muscles. Persistent upper limb impairments can lead to limitations in activities of daily living, and quality of life. Assistive devices to facilitate the use of the hemiplegic upper extremity are considered to be the most important modalities in improving the functions of the upper limb. The splint is one of the most assistive tools in the rehabilitation of such individuals. The supportive and corrective functions provided by upper limb and hand splints have been shown to inhibit spasticity and promote the capabilities of the upper limb in individuals with stroke This study aims to evaluate the effectiveness of spiral strapping on inhibition of spasticity and improving upper limb functions in individuals with chronic stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Splints, Physical Disability
Keywords
Stroke, Upper Limb Functions, Spiral Strapping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Individuals who will participate in the control group will receive a traditional functional exercise training protocol (conventional physiotherapy program) for one hour. It will focus on the enhancement of muscle strength, joint range of motion, arm &hand activities, and daily living functions of the affected upper limbs.
The treatment, for the control group, will be conducted over a period of 4 successive weeks, with 3 sessions per week.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive the conventional treatment program similar to that will be provided to the control group. The treatment, for the experimental group, will be conducted over a period of 4 successive weeks, with 3 sessions per week.
Moreover, they will ¬wear an upper limb spiral strapping system with a hand splint 8 hours daily/ 6 days per week.
Intervention Type
Device
Intervention Name(s)
TogRite stretch Strapping
Intervention Description
it is a machine washable and highly durable elastic strap that maintains its recoil strength for a long-lasting period. It is made of latex-free materials. The TogRite Strapping can be used to support the weakened parts of the body and adjust or modify the position and posture of different body parts.
Intervention Type
Other
Intervention Name(s)
Traditional upper limb functional exercise training
Intervention Description
The traditional upper limb functional exercise training will focus on the enhancement of muscle strength, joint range of motion, arm &hand activities, and daily living functions of the affected upper limbs.
Primary Outcome Measure Information:
Title
Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
Description
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia. It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
Time Frame
[Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Title
Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
Description
Modified Ashworth Scale was used to evaluate the degree of spasticity in the involved upper limb in the elbow and wrist joints. MAS is a valid and a reliable scale to evaluate the degree of muscle tone for all participants pre and post treatment. It is scored on a 6 -graded ordinal scale.
Time Frame
[Data was collected at baseline, and 4weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Title
Change in the upper limb' joints range of motion (in degree)
Description
Digital Goniometer was used to evaluate the following joints range of motion (shoulder abduction& external rotation, elbow extension and forearm supination). The Digital Goniometer has used a sensor to calculate the amount of joint range of motion in degrees to measure the true range of motion value.
Time Frame
[Data was collected at baseline, and 4 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
Secondary Outcome Measure Information:
Title
Change in the Hand Grip Strength of the involved upper extremity (Kg) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
Description
Hand Grip Dynamometer was used to assess the change in the strength of the hand muscles of the involved upper extremity. The higher the score of the hand grip after completion of the treatment program compared to the baseline score, the better the improvement of hand functional abilities.
Time Frame
[Data was collected at baseline, and 4 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 4 weeks of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria were as follow:
Participants were diagnosed as chronic stroke patients.
Participants were selected to be in the spastic phase.
The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+&2) according to Modified Ashworth Scale.
Participants were all between 50 and 60 years old, of both sexes.
Participants were cognitively able to understand and follow instructions.
Participants had the ability to extend their wrist joints at least 20° and fingers 10° from full flexion. This range allowed participants to engage easily in performing a designed functional program.
Exclusion Criteria:
The exclusion criteria were as follow:
Participants who were with any orthopedic condition or fixed deformity that interfere with the upper limb functions.
Participants who were with spasticity of more than score 2 according to the Modified Ashworth Scale.
Participants who had cognitive or perceptual problems.
Participants with seizures, visual impairments, or auditory problems.
Participants who had shoulder pain on a visual analogue scale of > 6/10.
Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehab M Abd El Kafy, PhD
Phone
+966531698541
Email
emkafy@uqu.edu.sa
Facility Information:
Facility Name
Ehab Mohamed Abd El Kafy
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehab M Abd El Kafy, PhD
Phone
0531698541
Email
emkafy@uqu.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
- The data available is Case-by-case basis at the discretion of the Primary Sponsor
IPD Sharing Time Frame
Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
IPD Sharing Access Criteria
Data can be obtained by the Principal Investigator. Email Address: emkafy@uqu.edu.sa
Learn more about this trial
Spiral Strapping for Improving Upper Limb Functions
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