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Completed

NCT Number: NCT05725941

Spiral Strapping for Improving Upper Limb Functions

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Physical Disability Splints Vascular Diseases

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, 21955, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TogRite stretch Strapping

Device

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.

Traditional upper limb functional exercise training

Other

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 outcomes

  1. Change in the score of The Action Research Arm Test (test that assess the change in upper extremity 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)

    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.

  2. Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)

    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)

    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.

  3. Change in the upper limb' joints range of motion (in degree)

    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)

    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 outcomes

  1. 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).

    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)

    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.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Collaborators

  • Princess Nourah Bint Abdulrahman University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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