Clinical trial NCT05725941: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Splints
Physical Disability
Keywords: Stroke
Upper Limb Functions
Spiral Strapping
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2023-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
timeFrame: [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)
measure: Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
timeFrame: [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)
measure: Change in the upper limb' joints range of motion (in degree)
timeFrame: [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 outcomes:
measure: 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).
timeFrame: [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)
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Ehab Mohamed Abd El Kafy
Study officials:
References: