Ethical approval

The study proposal was ethically approved by Departmental Research Committee, Ravi Nair Physiotherapy College on 31^st March, 2021 with reference number DMIMS(DU)/IEC/2021/235. It was registered in the Clinical Trial Registry-India (CTRI) with the registration number CTRI/2021/05/033498. The preprint of this protocol is presently available with digital object identifier (doi) https://doi.org/10.21203/rs.3.pex-1340/v1 in the repository named The Protocol Exchange [14].

Study design

This randomized parallel group 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 and Clinical Trial Registry-India. Before inclusion, all the participants will be informed regarding the aim and procedure of research. Those participants who will meet the inclusion criteria must give the written informed consent. In an experimental study, those participants (N = 40) diagnosed with DRF will be enrolled for six weeks protocol. Fig 1 shows the flow chart of the study.

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Fig 1. Study flow-chart.

Step-wise procedural plan of recruitment, allocation, intervention, and statistical analysis of the study.

https://doi.org/10.1371/journal.pone.0267549.g001

Trial design

It is a randomized parallel group trial in which the patients will be allocated into two independent groups. Group A will be control group getting the conventional physiotherapy rehabilitation program while Group B will be assigned with experimental group. The method that will be used for generating random sequence will be computer generated randomisation. The concealment will be done by sequentially numbered, sealed, opaque envelopes method and the participant will be blinded in the study.

Participants

The inclusion criteria includes 18–45 years age patient with DRF conservatively managed in a cast or managed with the k-wires under a cast, no previous history of wrist/ hand fracture, history of inflammatory arthritis, or any possible upper limb fracture and ability to recognize and obey basic verbal instructions [15].

The exclusion criteria includes patients with bilateral fracture, patients with past trauma either in arms or hands that had impaired function, rheumatic and neurological disorder patients, malignant conditions and symptomatic osteoarthritis of wrist and hand.

Sample size consideration

This is an experimental study with two-groups design that examine the effect of leap motion control in distal radius fracture rehabilitation. Analysis of previous power using G*Power is used to determine the sample size [16]. 40 participants will be enrolled to the control group or experimental group and will be allocated accordingly [12]. The G*Power analysis followed the following terms for calculation of sample size which is graphical represented in Fig 2.

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Fig 2. The calculation of sample size using G*Power analysis.

Graphical representation of the distribution of power on X-axis versus total sample size on Y-axis.

https://doi.org/10.1371/journal.pone.0267549.g002

1. t tests—Means: Difference between two independent means (two groups)
2. Analysis: A priori: Compute required sample size
3. Input:   Tail(s)      =   One
4.      Effect size d     =   0.8
5.      α err prob     =   0.2
6.      Power (1-β err prob)      =   0.95
7.      Allocation ratio N2/N1    =   1
8. Output:   Non-centrality parameter δ    =   2.5298221
9.      Critical t    =   0.8511828
10.      Df       =   38
11.      Sample size group 1    =   20
12.      Sample size group 2    =   20
13.      Total sample size      =   40
14.      Actual power        =   0.9531573

Intervention design

Group A: Those subjects in control group should undergo conventional training for 60 minutes a day, five days a week for six weeks. This group will receive conventional physiotherapy program consisting of Whirlpool, Joint mobilisation (Maitland, Kalternborn grade-1 gliding, grip strength exercises, scapular retraction exercises, Home Exercise Program (HEP). Some of the most common therapeutic approaches used to optimize the patient’s functional recovery are physical pain management strategies such as TENS, heat therapy. The range of motion (ROM) exercises would include passive mobilization of forearm and wrist, active exercises and active-assisted exercises for forearm, wrist, and fingers [7]. The PT strengthening plan includes exercises to strengthen wrist and finger flexors and extensors, forearm supinators and pronators (against therapist’s manual resistance and/ or elastic bands), and gripping activities (using several soft balls). Conventional therapy will be structured to replicate the skills needed in the leap motion environment with comparable intensity and complexity. Study researchers would encourage and supervise participants to ensure the consistency of the study.

Group B: Those subjects in experimental group with the Leap motion control will be asked to actively move their fingers from initial resting position and execute maximally the following five movements with their wrist and hand: fingers flexion and extension, flexion and extension of the thumb, wrist radial and ulnar deviation, forearm pronation and supination and wrist flexion and extension [3] for 30 minutes regularly. Rehabilitation games include-

1. Rhythm game: This game is aimed at helping patients perform flexion exercises for wrist joint. The buttons fall from above as music plays in the background, and must be pushed at the right time by the player.
2. Flappy Bird Clone: It is designed for wrist flexion and extension both in which the player is asked to control a bird flying over a series of tubes before the track ends.
3. Skiing Game: It requires wrist movement i.e. either extension or flexion and wrist radial or ulnar deviation. A skier who comes down a slalom track is guided by the player and must cross the gates [17].

Outcome measures

Primary outcome measure:

1. Disabilities of the Arm, Shoulder, and Hand Outcome Questionnaire (DASH): It is a 30- item questionnaire that evaluates the patient’s ability to perform upper extremity activities for functionality [18].
2. Universal Goniometer for ROM: Active flexion and extension of the wrist will be measured by a Standard BASELINE® 12-inch plastic goniometer, (Model 12–1000) Fabrication Enterprises, Inc: White Plains, New York. Participants will be assessed to expose their arms in a seated position and to remove any accessories [19].

Secondary outcome measure:

1. Grip strength: To check grip strength a Jamar (5030J1) Hydraulic dynamometer by JLW Instruments, Chicago, will be used. The participants would be tested in sitting position, with their arm placed to the side of the body; their shoulders in neutral position, elbow in 90° of flexion, and forearm in neutral [19]. Then, subjects will be asked with all their strength to make tight fists to maintain that position for four seconds and then rest for 30 seconds. First, the unaffected side will be tested and then affected side will be tested. The maximum value obtained from 3 trials will be recorded.
2. VAS: The visual analogue scale 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” (10). The subjects will be asked to draw a straight line illustrating the severity of the pain felt during the assessment.

Follow up

All patients will be followed up at six weeks after rehabilitation and follow-up record forms will be completed. The time of the last rehabilitation training session will be recorded. Electronic follow-up rehabilitation records will be preserved. When patients drop out of the trial, the reasons for withdrawal will be recorded in detail. Comprehensive and supportive patient communication will be undertaken; patients lost to follow-up because of any reason will be got in touch as soon as possible and be followed up within six weeks. Data regarding patients withdrawal from the study will be included in the final analysis, according to the intention-to-treat analysis principle.

Data management

Data from the trial will be kept in a secure, locked storage area with limited access for later review by a biostatistician, a researcher in charge.

Power analysis

The primary outcome measure will be a DASH score in the study with the minimal clinically important difference (MCID) of 10.83 points and standard deviation (SD) of 12.85 points [20]. In power calculations, we calculated the sample size required per group to be 20 patients with 95% confidence interval, power of 0.95 and effect size of 0.8. Therefore 20 patients in both groups have to complete 6 weeks of follow-up to have adequate statistical power.

Statistical analysis

The SPSS (27.0) will be used to perform statistical analysis. To compare the group effect, two-way repeated measures analysis of variance (ANOVA) will be used. If subjects are lost to follow up, an intention-to-treat analysis will be carried out. When ANOVA reveals a significant difference, student’s t test will be used to compare the changes within the group. Statistical significance is determined by a two-sided p value of less than 0.05. Mann-Whitney U, t-test or Fisher’s exact test will be used for comparing Groups at baseline. Mann-Whitney U test will be used to compare primary and secondary outcomes between the groups at 6 weeks.