The retrospective observational cohort study was conducted in accordance with the Declaration of Helsinki17 and was approved by the Ethics Committee of Linyi People’s Hospital (Approval No. 202512-H-030). As this was a retrospective analysis of archived clinical data, the requirement for informed consent was waived. All data were anonymized to ensure participant confidentiality. This study is reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for retrospective cohort studies. A completed STROBE checklist is provided as Supplementary File 1. The research tools used in the protocol are listed in the Table of Materials.
1. Study Setting
This retrospective study was conducted at a single sports medicine clinic in Tianjin, China. Medical records of patients diagnosed with sports injuries between January 2023 and January 2025 were reviewed.
2. Participant Selection and Sampling
Patients were eligible for inclusion if a diagnosis of sports injury was confirmed by imaging and clinical examination, including conditions such as knee ligament injuries, ankle sprains, or muscle strains. Additional inclusion criteria included presentation within 72 h of injury, age between 18 and 50 years, absence of severe underlying conditions such as osteoporosis or neuropathy, and availability of complete clinical records. Patients were excluded if injuries involved fractures or dislocations, if there was a prior injury at the same anatomical site, if there was an allergy to physical therapy modalities, or if there was an inability to comply with exercise therapy18.
A total of 192 patients with sports injuries were initially screened. Of these, 7 patients were excluded for the following reasons: incomplete clinical records (n = 3), presentation more than 72 h after injury (n = 2), age outside the 18–50 years range (n = 1), and prior injury at the same anatomical site (n = 1). Consequently, 185 patients met all eligibility criteria and were included in the analysis. The study design was a retrospective observational cohort study, with group allocation determined by the treatment received in routine clinical practice. Patients were categorized into a Physiotherapy group (n = 90) and a Comprehensive Therapy group (n = 95). This non-randomized design is susceptible to selection bias and confounding by indication. Baseline characteristics were compared between groups (Table 1), and no significant differences were observed for age, gender, BMI, smoking, drinking, affected side, or injury location (all P > 0.05). No propensity score matching or multivariable adjustment was performed due to the exploratory nature of this study and the absence of significant baseline imbalances. Assessments were conducted at baseline and at 2, 4, and 8 weeks following treatment initiation. The study workflow is presented in Figure 1.
| Variables | Physiotherapy group | Comprehensive group | 95% CI | Effect size | P-value |
| (n = 90) | (n = 95) |
| Gender | | | | | |
| Male | 47 (52.22) | 50 (52.63) | - | 0.003 | 0.956 |
| Female | 43 (47.78) | 45 (47.37) |
| Age (years) | 33.60 ± 5.72 | 34.29 ± 5.52 | -2.325,0.940 | -0.084 | 0.402 |
| BMI (kg/m2) | 22.06 ± 1.35 | 22.11 ± 1.31 | -0.444,0.327 | -0.3 | 0.764 |
| Affected side | | | | | |
| Left | 42 (46.67) | 46 (48.42) | - | 0.057 | 0.811 |
| Right | 48 (53.33) | 49 (51.58) |
| Injury location | | | | | |
| Knee | 38 (42.22) | 40 (42.11) | - | 0.215 | 0.898 |
| Ankle | 35 (38.89) | 38 (40.00) |
| Other (muscle strain, etc.) | 17 (18.89) | 17 (17.89) |
| Smoking history | 35 (38.89) | 43 (45.26) | - | 0.77 | 0.38 |
| History of drinking | 21 (23.33) | 27 (28.42) | - | 0.623 | 0.43 |
Table 1: Baseline characteristics of study participants. Comparison of demographic and clinical characteristics between the Physiotherapy group and the Comprehensive Therapy group, including gender, age, body mass index (BMI), smoking history, drinking history, affected side, and injury location. Data are presented as mean ± standard deviation or number (percentage). BMI, body mass index; CI, confidence interval.

Figure 1: Research flowchart. Flow diagram illustrating patient selection, group allocation, and follow-up assessment time points. Please click here to view a larger version of this figure.
3. Sample Size Calculation
Sample size estimation was performed using statistical software, assuming an effect size of 0.5, a significance level of 0.05 (two-tailed), and a statistical power of 0.90. The calculated minimum sample size was 70 participants per group, for a total of 140 participants. The final sample size of 185 exceeded this requirement19.
4. Treatment Methods
All physical therapists involved in the study had more than five years of clinical experience and held nationally certified qualifications. Treatment was administered over an 8-week period at a frequency of five sessions per week20,21,22.
All treatment protocols were individualized according to injury type and severity, pain level, range of motion, muscle strength, and functional capacity. The standardized rehabilitation framework described below provided the overall treatment structure, whereas exercise selection, resistance level, and progression were adjusted at each session based on clinical reassessment and patient tolerance.
In the Physiotherapy group, treatment was delivered in sequential phases. The selection of specific physical therapy modalities was based on the phase of tissue healing and the patient's clinical presentation. During the acute phase (days 1–7), cold compress therapy (15 min twice daily) and low-frequency pulse electrotherapy (biphasic pulsed current, 50 Hz, 200 µs pulse duration, intensity adjusted to visible muscle contraction; 20 min/session) were administered to reduce acute pain and inflammation. During the subacute phase (days 8–21), ultrasound therapy (1 MHz, 1.0 W/cm2, continuous mode, 5 cm2 treatment head; 10 min/session) was combined with manual soft tissue and joint mobilization (15 min/session) to promote tissue repair, reduce adhesions, and improve tissue extensibility. During the recovery phase (days 22–56), infrared heat therapy (at a distance of 30 cm, with skin temperature maintained at 40–43 °C) was applied for 20 min per session to improve local blood circulation. Treatment parameters were adjusted based on individual tolerance and response, with progression determined by clinical reassessment at each session.
In the Comprehensive Therapy group, the same physical therapy regimen was combined with staged exercise therapy. Exercise prescription followed the FITT principles (Frequency, Intensity, Time, Type) and was individualized for each patient. Sessions were performed five times per week. Exercise intensity was monitored using the Borg CR-10 Rating of Perceived Exertion (RPE), targeting scores of 3–4 ("moderate") during the early stages and 5–6 ("somewhat hard to hard") during the later stages. Exercise type, resistance level, session duration, sets, and repetitions were selected according to injury type, functional deficits, baseline strength, patient tolerance, and fatigue level, and were reviewed weekly based on clinical reassessment. The type of exercise was determined by the patient's specific injury and functional deficits, with stage-appropriate exercises selected from a standardized menu of options. All exercise parameters were reviewed and adjusted weekly based on clinical reassessment. During the initial stage (days 1–7), passive joint range-of-motion exercises were performed for 10 min per session, along with isometric contractions, while active weight-bearing was avoided. During the second stage (days 8–21), active range-of-motion exercises were introduced within a pain-free range, along with low-load resistance training using elastic bands, typically performed as three sets of 20 repetitions. Resistance intensity was standardized using color-coded elastic bands selected according to each patient's baseline strength and tolerance, with progression to higher resistance levels as strength improved. Exercise intensity was monitored using the Borg CR-10 Rating of Perceived Exertion (RPE), with a target of 3–4 (“moderate”) during this stage. Formal % 1RM testing was not performed during this phase, as patients were in the subacute stage with varying pain levels, making such testing clinically impractical and potentially unsafe. During the third stage (days 22–35), balance training, including single-leg stance for 30 s, repeated 3 times, and coordination exercises such as stair training, were implemented. During the final stage (days 36–56), functional training, including jogging for 10–20 min and shuttle runs consisting of five 10-meter repetitions, was introduced to progressively restore athletic function.
Progression between stages was based on predefined clinical criteria, including a resting Numerical Rating Scale (NRS) score below 3, no new or worsening pain, and the achievement of specific functional milestones. Stage 1 was fixed at 7 days. For subsequent stages, the following objective functional criteria were required: from stage 1–2, ability to perform straight leg raise without pain; from stage 2–3, knee flexion ≥ 90° with minimal pain and ability to perform 10 single-leg stances without loss of balance; from stage 3–4, ≥ 90% limb symmetry index on single-leg hop test and NRS score < 2 during activity. Each stage beyond stage 1 was typically maintained for 10–14 days, depending on the individual's recovery progress. Movement quality was assessed by experienced physical therapists (>5 years of clinical experience) using standardized observations of the following indicators: maintenance of neutral knee alignment during single-leg stance and squatting, absence of pelvic drop (Trendelenburg sign) during single-leg stance, and symmetrical weight distribution during bilateral squatting. Video recordings were reviewed as needed for confirmation, and inter-rater reliability (κ = 0.82) was established from 20 randomly selected video assessments.
Adherence to the intervention was monitored through therapist-recorded attendance and patient-maintained home exercise logs. Adherence was defined as attendance at 80% or more of scheduled sessions and completion of at least 70% of prescribed home exercises. All participants were included in the analysis regardless of adherence level in accordance with the as-treated principle. To ensure reproducibility, therapists followed a standardized treatment manual supplemented with instructional materials, and exercise parameters were prescribed according to the FITT principles.
5. Observation Indicators
The primary outcome was motor function at 8 weeks, assessed using the Lysholm score23, which ranges from 0–100, with higher scores indicating better function. The Lysholm score was analyzed only in patients with knee injuries.
Secondary outcomes included pain, assessed using the 0–10 Numerical Rating Scale at baseline and at 2, 4, and 8 weeks24; functional recovery, American Orthopaedic Foot and Ankle Society (AOFAS) score in patients with ankle injuries; dynamic balance, measured using the Star Excursion Balance Test25; and quality of life, assessed using the Short Form-36 questionnaire26, which includes eight domains covering physical and mental health. Safety outcomes were evaluated by recording adverse reactions, including local swelling, muscle soreness, and skin irritation, based on clinical records and patient self-reports.
6. Statistical Analysis
Data were analyzed using statistical software. Continuous variables were expressed as mean ± standard deviation. For repeated-measures outcomes with four time points (baseline, 2, 4, and 8 weeks), including NRS and AOFAS scores, linear mixed-effects models were fitted with group, time, and group-by-time interaction as fixed effects, and participant-specific random intercepts. For outcomes assessed at two time points (baseline and 8 weeks), including Lysholm score, Star Excursion Balance Test, and Short Form-36 domains, two-way repeated-measures analysis of variance was performed with group and time as fixed factors. For site-specific outcome measures (Lysholm and AOFAS), analyses were restricted to the corresponding injury subgroups (knee for Lysholm; ankle for AOFAS). Post hoc comparisons were adjusted using the Bonferroni correction. Categorical variables were analyzed using the chi-square test or Fisher’s exact test. Effect sizes were reported as Cohen’s d. For the Star Excursion Balance Test, a Mann–Whitney U test was additionally performed to confirm robustness. A two-sided P-value less than 0.05 was considered statistically significant. In this retrospective study using archived clinical records, only patients with complete medical records were included, per the eligibility criterion "availability of complete clinical records". Therefore, no missing data were present for the primary or secondary outcomes at any time point.