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 Table of Contents  
RESEARCH PROTOCOL
Year : 2021  |  Volume : 16  |  Issue : 1  |  Page : 229-234

A novel research protocol for single-blinded randomized trial for evaluating the impact of gamification on functional independence and health-related quality of life post distal radius fracture


Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences (Deemed to be University), Wardha, Maharashtra, India

Date of Submission27-Jul-2020
Date of Decision21-Dec-2020
Date of Acceptance15-Feb-2021
Date of Web Publication29-Jul-2021

Correspondence Address:
Dr. Waqar Naqvi
Ravi Nair Physiotherapy College, Wardha, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdmimsu.jdmimsu_283_20

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  Abstract 


Background: Distal radius fracture (DRF) is the frequently occurring fracture in the upper extremity among all age groups. Physiotherapy is vividly used to optimize recovery and regain functional independence following a distal radial fracture. To date, however, work on virtual reality (VR)-based rehabilitation in patients with DRF is limited. This research aims to evaluate the impact of gamification on functional independence and health-related quality of life in post-DRF. Methodology: In a single-blinded randomized controlled trial, the participants (n = 40) with DRF will be recruited. The participants will be enrolled into either an experimental or control group with 1:1 allocation ratio. Participants in the intervention group will undergo both VR training using oculus and conventional therapy for 6 weeks, and the participants in the conventional group will undergo only conventional therapy. Functional independence and HWQoL will be assessed using (patient-rated wrist evaluation) scale, Michigan hand outcomes questionnaire and disabilities of the arm, shoulder, and hand (DASH) Outcome Questionnaire throughout the treatment duration and after 6 weeks of rehabilitation. Result: There is significant impact of gamification on functional independence and health-related quality of life post distal radius fracture. Conclusion: This research seeks to examine the rapid and long-term results of VR-based rehabilitation in post DRF patients. The findings of this study will help prospective patients with DRF, which may include a newly designed method of rehabilitation.

Keywords: Distal radius fracture, functional independence, gamification, oculus quest, virtual reality


How to cite this article:
Naqvi W, Qureshi M, Phansopkar P. A novel research protocol for single-blinded randomized trial for evaluating the impact of gamification on functional independence and health-related quality of life post distal radius fracture. J Datta Meghe Inst Med Sci Univ 2021;16:229-34

How to cite this URL:
Naqvi W, Qureshi M, Phansopkar P. A novel research protocol for single-blinded randomized trial for evaluating the impact of gamification on functional independence and health-related quality of life post distal radius fracture. J Datta Meghe Inst Med Sci Univ [serial online] 2021 [cited 2021 Sep 16];16:229-34. Available from: http://www.journaldmims.com/text.asp?2021/16/1/229/322624




  Introduction Top


Distal radius fracture (DRF) is a frequently occurring fracture around the wrist joint worldwide.[1] Usually, a DRF is marked by a fragility fracture, that occurs about 2 cm above the distal end of the radius at the intersection where the cortical bone is strengthened by the trabecular bone network.[2] Often, it occurs due to a fall on an extended hand.[3] Given the characteristics of the injury, DRF may be classified into Colles, Barton, Smith, Monteggia, Galeazzi, or Hutchinson fractures. DRF is a prevalent fracture among the adults, accounting for the majority of fractures in the emergency department.[4] A steady rise in the incidence of DRF has been noted in people between the ages of 20 and 80. Ageing is one of the key risk factors for reduction failure and secondary fracture displacement.[4] Typically, the DRFs are managed conservatively through closed reduction and immobilization in a plaster cast.[5] The patients gain full range of motion (ROM), strength and function within 3–6 months of fracture regardless of whether the fracture management was conservative or surgical.[6] Hand activity requires a combination of adequate sensation, proprioception, intact neurological control and coordination, appropriate anatomical alignment, and muscle strength and flexibility.[7]

Physical therapy (PT) is of critical importance to improve functional recovery following DRF.[4] PT is recommended for reducing pain, increasing ROM, and enhancing muscle function and muscle strength after the cessation of immobilization. PT management can be active or passive. Active management involves the active participation of the patient to carry out a supervised program by a physiotherapist or a home exercise program.[7] Passive management involves joint mobilization, massage, hot pack, transcutaneous electrical nerve stimulator, and ultrasound.[8] Virtual reality (VR) training program or gamification can be integrated into the treatment protocol for the management of DRF.

Gamification is a renowned expression in scientific research and several professional areas. Sebastian Deterding stated that gamification is described as the employing of game design elements in nongame contexts.[9] Gamification influences the behavior and motivation of the users using game reminiscent experiences. Employing game mechanics in physiotherapy is important in engaging and motivating the patient. In this, a virtual environment is created in which the therapist observes and motivates the patient thus enhancing the training program.[10] The use of VR technology in health care has shown a significant increase over the last two decades due to its ability to increase the training outcomes. VR-based training promotes learning, allows active participation of the patient, and enhances motivation during the rehabilitation.

The VR headset “Oculus Quest” interacts with the environment as per the patient's movements by permitting immersion into a virtual environment coupled with gestural control.[11] Oculus-Quest head-mounted display (HMD) will be used, which has 6° of freedom. It provides portability and allows the therapist to change the location as per. The current applications include gaming, education, maps, and navigating the computer desktop. The technology lends itself to monitoring hand movement exercises used for wrist physiotherapy. However, there is no existing research investigating the feasibility and validity of using this technology in DRF.


  Methodology Top


Aim

This study aims to evaluate the impact of gamification on functional independence and health-related quality of life (HRQoL) post DRF.

Study setting

This trial will be carried out in the HumEn research lab of Ravi Nair Physiotherapy College, Sawangi (Meghe), Wardha, after approval from Institutional Ethics Committee of Datta Meghe Institute of Medical Sciences, Deemed to be University.

Study design and sample size

The study design is a single-blinded randomized controlled trial study of VR-based rehabilitation system in patients with post-DRF, which can lead to functional limitation of wrist complex. In this study, the participants (n = 40) will be enrolled for 6 weeks of physiotherapy.[8] The subjects will be randomized into two Groups-A and B. Group A or control group will be given the conventional rehabilitation program, while Group B or experimental group will be given the VR-based rehabilitation program.

The procedure of the study is illustrated in [Figure 1] and the schedule of enrollment, interventions, and assessments of the study (as recommended by Standard protocol items: Recommendation for intervention trials [spirit], 2013)[12] is illustrated in [Table 1].
Figure 1: Flow diagram of the study procedure

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Table 1: Schedule of enrollment, interventions, and assessments

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Participants

Inclusion criteria for the recruitment are:

  1. DRF patients with visible X-ray displacement
  2. 18 years of age or older
  3. Conservatively managed in a cast. The k-wires used under a cast was permitted, as this method of immobilization is commonly used (for minimum 4 weeks)
  4. Ability to recognize and obey basic verbal instructions
  5. Patient willing to participate.[13]


Exclusion criteria are as follows:

  1. Patients with the bilateral fracture
  2. Patients with any possible upper limb fracture
  3. Patients with a history of trauma either in arms or hands leading to impaired function
  4. Patients with neurological disorder patients
  5. History of rheumatic or inflammatory arthritis
  6. Symptomatic osteoarthritis of wrist and hand
  7. Patient with upper limb malignancy
  8. Patients who are unwilling to participate.


Participant timeline

Each patient will be required to complete 6 weeks of conventional rehabilitation or VR + conventional rehabilitation after enrollment in the study. The evaluations (patient-rated wrist evaluation [PRWE], disabilities of the arm, shoulder, and hand [DASH] and Michigan hand outcomes questionnaire [MHQ]) will be performed at baseline and before their last session.

Recruitment

The orthopedic surgeons and primary care providers working under DMIMSU are invited to refer the prospective patients to our inpatient department. The patients who are diagnosed with post immobilization with minimum 4 weeks' following DRF will be systematically assessed for the eligibility in the research as per the eligibility criteria. The subjects who satisfy the eligibility criteria will undergo the Oculus Quest trial run to evaluate their tolerance to the device. A comfortable VR experience requires an unimpaired sense of motion and balance. Experiencing any following symptoms the trial was terminated (headaches, migraine, tired, sleepy, under influence of alcohol or drugs, under emotional stress or anxiety). In the trial, they will perform several exercises for 10 min. Only those patients who have an 80% or higher adaptability to the VR system will undergo randomization. Before recruitment, all the subjects will be informed about the purpose, benefits, hazards, and procedure of the research following which written informed patient consent form will be taken.

Study procedure

The participants will be categorized into two groups:

  • Group A (conventional rehabilitation): The participants in the control group will undergo conventional rehabilitation for 60 min a day, 5 days a week for 6 weeks. This group will receive conventional physiotherapy program consisting of ROM exercises. It will include graded passive mobilization of forearm and wrist, active and active-assisted exercises of forearm, wrist, and fingers with progressing to active and active resisted with therabands. The PT strengthening exercises include strengthening exercises for wrist extensors and flexors, forearm supinators and pronators, finger flexors and extensors, and gripping activities (using several softballs). Progression in the exercises was considered with increasing intensity and repetitions. Post session pain would be managed by ice application. Conventional therapy will be formulated to imitate the skills needed in the VR training, with comparable intensity and complexity
  • Group B (VR-based rehabilitation with conventional rehabilitation): The participants in the intervention group will undergo VR training and conventional training, each for 30 min a day, 5 days a week for 6 weeks. They will be required to perform several activities during the regular 30-min VR intervention using oculus quest.[10] The patient will be able to look around using the oculus quest HMD by simply moving his head. It allows for a high level of immersion.


Virtual reality rehabilitation protocol

It consists of the following:

  1. Oculus quest HMD;
  2. A pair of wireless controllers;
  3. ASUS GeForce GTX 1650 Overclocked 4GB Graphics Card;
  4. A computer with a 4-core Intel® Core™ i5-4590 at 3.30 GHz, 8-GB RAM; and
  5. 2 base stations to track the participant's precise movement and position through the headset and controllers;


With the Oculus Quest, the participants will be asked to actively move their fingers, wrist, and forearm from an initial resting position and execute maximally the following six movements, which include fingers flexion and extension, thumb adduction, abduction, flexion and extension, wrist ulnar and radial deviation, forearm pronation and supination, and wrist flexion and extension.[14] Rehabilitation games will aim to help patients perform the above-mentioned exercises through the games developed solely for the rehabilitation of patients following DRF.[15]

Outcome measures

Primary outcome measure

The primary outcome measures will be evaluated using the PRWE scale, DASH Outcome Questionnaire and MHQ. The PRWE is a 0-100-point scale that will be used to evaluate pain, ROM, grip strength, daily activities, and specific activity of the wrist joint. Higher PRWE score will indicate more severe joint pain and dysfunction.[16] DASH questionnaire has 30-items, which will evaluate the patient's potential to perform certain activities of the upper extremity. The MHQ will be applied to assess overall hand function, daily living activities, pain, work performance, esthetics, and satisfaction with hand function.

Secondary outcome measure

The secondary outcomes include grip strength, visual analog scale (VAS), ROM and scale of depression, anxiety and stress-21 (DASS-21). Grip strength will be checked by Jamar dynamometer in sitting position, with their arm placed to the side of the body, their shoulders in the neutral position, elbow in 90 degrees of flexion, and forearm in neutral.[17] Then, subjects will be asked with all their strength to make tight fists to maintain that position for 4 s and then rest for 30 s. The VAS is a measurement scale for pain, consisting straight line of 10-cm, the left edge shows “no pain” (0) and the far-right edge shows the “worst pain imaginable.” The subjects will be asked to draw a straight line illustrating the severity of the pain felt during the assessment. Active and passive ROM of the forearm, wrist joint, metacarpophalangeal joints, and interphalangeal joints will be measured by a goniometer.[17] The DASS-21 will be used to assess the emotional states of DASS-21.

Follow up

All patients will be followed up at 6 weeks after rehabilitation and follow-up record forms will be completed. The time of the last rehabilitation training session will be recorded. Data regarding patients withdrawn from the trial will be included in the final analysis. Comprehensive and supportive patient communication will be undertaken; patients lost to follow-up because of any cause will be gotten in touch as soon as possible and be followed up within 6 weeks.

Data collection and management

Data collection

The data for assessment data will be collected from a predetermined spreadsheet with the baseline characteristics variable. A secured database will have recordings of the testing data. The hard copies of assessment forms and signed consent forms will be kept securely on the study site. The electronic data from the Oculus quest and the gaming system will be stored in DMIMSU's electronic repository as per participant ID. To retain participants, financial incentives will be given to the needful for attending testing sessions.

Data management

The principal investigators will collect and document the data. The data will be examined thoroughly for accuracy before documentation. An allocation blinded statistician will be given the Excel spreadsheet at the end of the study for conducting the necessary analysis. After this, the unblinding of the groups will be done. Checklists will be maintained to avoid missing data.

Statistical analysis plan

Therapy-induced changes in the primary outcome measures will be analyzed through mixed-effects linear models across TIME (preintervention vs. postintervention) and GROUP (Intervention vs. Control). To assess which combination of stimulation and practice modality will result in greater improvements, we will use the analysis of variance. The significance will be carried out by P < 0.05. Mann–Whitney U-test or t-test will be used to compare groups at baseline. The results will be reported as per the CONSORT guidelines.[20],[21],[22],[23],[24]


  Discussion Top


The purpose of this research is to check the impact of VR training on functional independence and HRQoL in post DRF patients. Nonetheless, it is proposed that gamification may have positive effects in enhancing patient's function independence of hand and HRQoL after DRF because the VR training programs aim to improve motion control and more engage patient in motion learning. This research seeks to examine the rapid and long-term effects of immersive VR in DRF patients. According to some studies, rehabilitation through gamification has the potential to decrease disability.[18] VR training programs are more acceptable and exercisable and more comfortable and engaging in physiotherapy because of modernization due to the impacts of technological developments. Gamification has demonstrated to reduce pain and anxiety during the rehabilitation program.[19] There is minimal research on the impact of gamification in postfracture rehabilitation. For this reason, this study may be important for further studies. The findings of this research may or may not provide evidence supporting this hypothesis. The study findings would help prospective patients with DRF, which may include a newly designed method of rehabilitation.

Ethics and dissemination

The protocol is designed according to the guidelines of the Helsinki declaration for conducting research. The main findings regarding the efficacy of the VR training to enhance post-DRF functional independence and HRQoL will be published in a peer reviewed journal. The personal data of the recruited subjects will be kept securely for a minimum of 5 years. The data will be stored in the DMIMSU data repository after accomplishing the research.

Patient consent

Principal investigator will obtain the informed consent from the patient and one of the relatives on a printed form with signatures and give the proof of confidentiality.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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