NCT06231173

Brief Summary

Visual feedback therapy is a cheap, easy, and, most importantly, patient-directed treatment that may improve the recovery of hand motor functional skills. Visual feedback therapy consists of repeated bilateral, symmetrical movements in which the patient moves the affected body part as much as he/she could while observing the reflection.The hands account for less than 5 % of total body surface area. Many burns requiring hospitalization involve the upper extremity considered severe injuries by the American Burn Association and should be referred to specialized care centers to minimize sequella of thermal injury including nail deformities, hypertrophic scars, boutonniere deformity, digit loss, and contractures. Visual feedback therapy is a treatment method based on neuroplasticity of the brain.Although recent studies have demonstrated the benefit of visual feedback therapy for various diseases, research that applies visual feedback therapy to improve the restorative capability of hand function of patients with reduced hand function due to mutilated injury has not been reported yet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Burns, Goniometer, Hand contracturesVisual feedback therapy

Outcome Measures

Primary Outcomes (3)

  • Goniometer

    Goniometer both for upper and lower limb, is the simplest and most extended tool for measuring ROM in the clinical practice It was developed approximately 60 years ago, and its versatility and usability led to this instrument being promptly integrated into the field of physiotherapy and rehabilitation as a helpful evaluation tool. The intra-class correlation coefficients (ICC) ranged from 0.94 to 0.97 from the goniometric measurements

    4 weeks

  • THE ABILHAND

    The ABILHAND is a Rasch-based assessment that measures patients' perceived difficulty in performing ADLs that require the use of the bilateral upper limbs. It contains 23 items measuring manual ability and is rated on a 3-point response scale. The score, given in logits, is the conversion of the ordinal score into a linear measure of ability located on a unidimensional scale. The ABILHAND is a scale measuring bimanual ability that is often used to determine the level of UE dysfunction. Most of the validity studies on the ABILHAND demonstrated that the ABILHAND measured the concept of motor ability in a "standardized" or natural environment by significant correlations between the ABILHAND and grip strength, motricity, dexterity, or actual UE performance as measured by the accelerometers

    4 weeks

  • Visual analogue scale (VAS)

    Visual analogue scale (VAS) is a scale used for pain assessment, horizontal line 100mm in length, anchored by word descriptors at each end. The patient was asked to mark on the line the point they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks

    4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Visual feedback therapy and conventional therapy

Other: Visual Feedback Therapy and Conventional Therapy

Controlled

ACTIVE COMPARATOR

Conventional therapy

Other: Conventional Therapy

Interventions

In experimental group individuals will receive visual feedback therapy and Conventional rehabilitation therapy. In visual feedback therapy, bilateral method is used to receive the visual feedback from the mirror. This visual feedback therapy consists of the following parts as the patient is asked to follow the involved hand that did the mimicking while the non-involved side will be performing wrist flexion, wrist extension, ulnar deviation, radial deviation, supination, pronation, and closing hand and opening hand.In conventional therapy, Patients are given a rest time of 20 seconds in each activity and a 1-minute break in each segment in order to reduce fatigue of the noninvolved hand. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied according to subject's tolerance for duration of 15 minutes in each sitting. This treatment protocol will be 5 times/week for 4 weeks in the hospital setting.

Experimental

In control group individuals will receive only conventional therapy. In conventional therapy, Patients are instructed to perform a sandbag and hand grip exercise with a resistive exercise for the non-involved side. At last, patients are instructed to perform a moving small object (ball of wool) and card flip operation to induce wrist and finger movements as functional activities. Patients are given a rest time of 20 seconds in each activity and a 1-minute break in each segment in order to reduce fatigue of the non involved hand. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied according to subject's tolerance for duration of 15 minutes in each sitting. .This treatment protocol will be 5 times/week for 4 weeks in the hospital setting.

Controlled

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 12 years old children with post burn hand contractures
  • Patients with flame burns
  • Patients with 2nd degree burns

You may not qualify if:

  • Patients with hand burns with any post burn complications
  • Patients with wound infections
  • Patients with 3rd degree burns Patients with hand fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • Tofani M, Santecchia L, Conte A, Berardi A, Galeoto G, Sogos C, Petrarca M, Panuccio F, Castelli E. Effects of Mirror Neurons-Based Rehabilitation Techniques in Hand Injuries: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 May 2;19(9):5526. doi: 10.3390/ijerph19095526.

    PMID: 35564920BACKGROUND
  • Wang TN, Lin KC, Wu CY, Chung CY, Pei YC, Teng YK. Validity, responsiveness, and clinically important difference of the ABILHAND questionnaire in patients with stroke. Arch Phys Med Rehabil. 2011 Jul;92(7):1086-91. doi: 10.1016/j.apmr.2011.01.020.

    PMID: 21704789BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sana Mushtaq, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 30, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations