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Spiral Strapping for Improving Upper Limb Functions

U

Umm Al-Qura University

Status

Completed

Conditions

Stroke
Physical Disability
Splints

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05725941
RI-4-0588

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

50 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Control Group
Active Comparator group
Description:
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.
Treatment:
Other: Traditional upper limb functional exercise training
Experimental Group
Experimental group
Description:
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.
Treatment:
Other: Traditional upper limb functional exercise training
Device: TogRite stretch Strapping

Trial contacts and locations

1

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Central trial contact

Ehab M Abd El Kafy, PhD

Data sourced from clinicaltrials.gov

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