Spiral Strapping for Improving Upper Limb Functions

NCT ID: NCT05725941

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-25

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Stroke Splints Physical Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

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.

Group Type ACTIVE_COMPARATOR

Traditional upper limb functional exercise training

Intervention Type 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.

Experimental Group

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.

Group Type EXPERIMENTAL

TogRite stretch Strapping

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Nourah Bint Abdulrahman University

OTHER

Sponsor Role collaborator

Umm Al-Qura University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Mohamed Abd El Kafy

Professor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RI-4-0588

Identifier Type: -

Identifier Source: org_study_id

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