Spiral Strapping for Improving Upper Limb Functions

NCT05725941 | Completed

• 1 other identifier: RI-4-0588
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Splints; Physical Disability

Keywords

Stroke; Upper Limb Functions; Spiral Strapping

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 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).

  [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)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Other: Traditional upper limb functional exercise training

Experimental Group

EXPERIMENTAL

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.

Device: TogRite stretch Strapping; Other: Traditional upper limb functional exercise training

Interventions

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.

Experimental Group

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead
• Princess Nourah Bint Abdulrahman University: collaborator

Study Sites (1)

Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, 21955, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 13, 2023
• Study Start: January 25, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 30, 2023
• Last Updated: January 14, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by the Principal Investigator. Email Address: emkafy@uqu.edu.sa

Locations

SA (1)