Spiral Strapping for Improving Upper Limb Functions

Stroke Clinical Trial

Official title:

The Effectiveness of Spiral Strapping on Upper Limb Functions in Individuals With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725941
• Other study ID #: RI-4-0588
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: April 15, 2023

Study information

• Verified date: January 2023
• Source: Umm Al-Qura University
• Contact: Ehab M Abd El Kafy, PhD
• Phone: +966531698541
• Email: emkafy[@]uqu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 15, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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 ?ngers 10° from full ?exion. 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.

Related Conditions & MeSH terms

• Physical Disability
• Splints
• Stroke

Intervention

Device:
• TogRite stretch Strapping
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.

Other:
• Traditional upper limb functional exercise training
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.

Locations

Country	Name	City	State
Saudi Arabia	Ehab Mohamed Abd El Kafy	Mecca

Sponsors (2)

Lead Sponsor	Collaborator
Umm Al-Qura University	Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	[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)
Primary	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.	[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)
Primary	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.	[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	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.	[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)