Trial · NCT07894536
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Maximum Isometric Ankle Dorsiflexion Strength at Each Postoperative Time Point | Baseline (within 1 month before surgery) and 3, 6, 12, 24, 36, 48, and 60 months after surgery | Maximal voluntary isometric dorsiflexion strength (MVIC-DF) of the index ankle, measured with a hand-held dynamometer (make-test of 3-5 s performed three times with the participant seated, the knee flexed to 90 degrees and the ankle in neutral; mean of three trials) and normalized to body weight (N/kg). Change is computed as the postoperative value minus the baseline value. The threshold for a clinically meaningful change is 0.77 N/kg (MDC95). |
| Secondary | 1-Minute Walk Distance (1MWD) at Each Assessment | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Distance walked in 1 minute at habitual pace on a level 20-m straight course with usual footwear and orthosis/assistive device, recorded in meters. Higher values indicate better walking endurance. The 1-minute walk test shows good test-retest reliability and strong concurrent validity with the 6-minute walk test. |
| Secondary | 10-Meter Walk Test at Comfortable Speed (10MWT) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Gait speed over the central 10 m of a 14-m walkway with 2-m acceleration and deceleration zones, at self-selected comfortable speed, in meters per second; mean of 2 timed trials, usual assistive device permitted and recorded. Higher values indicate better walking speed. |
| Secondary | Active Ankle Dorsiflexion and Plantarflexion Range of Motion | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Active ankle dorsiflexion and plantarflexion arc measured with a universal goniometer using bony landmarks (fibular head, lateral malleolus, base of the fifth metatarsal), in degrees; mean of 3 measurements per direction. Higher dorsiflexion values indicate improved active ankle mobility; plantarflexion is reported descriptively. |
| Secondary | Passive Ankle Dorsiflexion and Plantarflexion Range of Motion | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Passive ankle dorsiflexion measured with the knee flexed 45 degrees (soleus component) and with the knee extended (gastrocnemius component); passive plantarflexion measured with the participant prone. Universal goniometer with bony landmarks, in degrees; mean of 3 measurements. Higher dorsiflexion values indicate improved passive ankle mobility. |
| Secondary | Charcot-Marie-Tooth Examination Score Version 2 (CMTESv2) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Composite impairment scale with 7 items scored 0-4: sensory symptoms; motor symptoms of legs and arms; pinprick sensibility with Neurotip; vibration with the Rydel-Seiffer graduated 128-Hz tuning fork at the great toe, medial malleolus and tibial tuberosity; MRC-graded leg strength; arm strength of the first dorsal interosseous or abductor pollicis brevis. Total range 0-28; lower scores indicate less impairment. |
| Secondary | Walk-12 Walking Ability Scale | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Patient-reported walking ability during the past month: 12 items rated 0-3 (no difficulty to unable), total 0-36. Higher scores indicate greater perceived walking limitation. |
| Secondary | Foot and Ankle Disability Index (FADI and FADI-Sport) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Foot- and ankle-specific patient-reported function: 26 items (8 pain, 18 function) converted to a percentage of the maximum possible score (0-100); FADI-Sport adds 8 sport-activity items converted the same way. Higher scores indicate better function. |
| Secondary | SF-12 Physical and Mental Component Summary Scores (PCS and MCS) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Generic health-related quality of life from the 12-item Short Form Survey, aggregated into physical (PCS) and mental (MCS) component summary scores, norm-based to a mean of 50 (SD 10); validated Chinese version used. Higher scores indicate better quality of life. |
| Secondary | Foot and Ankle Pain on the Numeric Rating Scale (NRS) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Average foot-ankle pain during the past week rated 0-10 (0 = no pain, 10 = worst imaginable pain) for rest, night and activity, one item each; analyzed as continuous scores. Lower values indicate less pain. |
| Secondary | Balance and Falls: Timed Up-and-Go, Single-Leg Stance, and Falls Count | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Timed up-and-go (TUG): time to rise from a chair, walk 3 m, return and sit down, in seconds, usual assistive device permitted; single-leg stance: maximum hold up to 30 seconds; falls: number of unintentional grounding events during the past 6 months. Lower or fewer values indicate better balance and fewer falls. |
| Secondary | Sensory Function: Rydel-Seiffer Vibration and Semmes-Weinstein Monofilament | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Vibration sense tested with the Rydel-Seiffer graduated 128-Hz tuning fork at the dorsal great toe interphalangeal joint and the medial malleolus, graded 0-8 (higher = better); light touch-pressure tested with the 10-g Semmes-Weinstein monofilament at 3 standard plantar sites (perceived or not perceived). |
| Secondary | Fatigue Severity Scale (FSS) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Self-reported fatigue: 9 items rated 1-7, reported as the mean score. Higher values indicate more severe fatigue. |
| Secondary | Muscle Cramp Frequency (4-Week Diary) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Prospective 4-week diary recording cramp episodes per week, anatomical distribution and presence of night cramps (yes/no). Lower frequency indicates fewer cramps. |
| Secondary | Ankle-Foot Orthosis (AFO) Use and Dependence | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | From a 7-day diary: type of orthosis, mean daily wear hours and percentage of walking episodes with the AFO. Reported descriptively; a postoperative reduction in orthosis dependence with maintained function is expected. |
| Secondary | Plantar and Dorsal Calluses and Fissures | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | Clinical inspection counting callosities and fissures on the plantar and dorsal foot using a standardized body map. Lower counts indicate less deformity-related skin burden. |
| Secondary | Weight-Bearing Radiographic Deformity Angles (Meary, Hibbs, Calcaneal Pitch) | Baseline and 12 months after surgery | Standardized weight-bearing anteroposterior and lateral foot radiographs (plus Saltzman hindfoot view as routine care): Meary angle (talo-first metatarsal), Hibbs angle (calcaneus-first metatarsal) and calcaneal pitch, in degrees, described against normal values. |
| Secondary | Emotional Distress Screen (PHQ-4) | Baseline (within 1 month before surgery) and at 3, 6, 12, 24, 36, 48, and 60 months after surgery | 4-item Patient Health Questionnaire combining 2 anxiety (GAD) and 2 depression (PHQ) items, total 0-12. Lower scores indicate less anxiety and depressive distress. |
| Other | Change in Fat Fraction of the Transferred Donor Muscle(s) at 12 Months (Optional MRI Sub-study) | Baseline and 12 months after surgery | Repeat Dixon MRI of the index limb at 12 months with the identical acquisition and region-of-interest protocol; proton density fat fraction (%) of the transferred donor muscle(s) is compared with baseline to characterize donor-muscle remodeling after transfer. Optional sub-study with separate consent. |
| Other | Incidence of Surgical and Study-Related Complications up to 60 Months | From surgery to 60 months postoperatively | Wound dehiscence or infection (superficial/deep), sural or other nerve injury, deep vein thrombosis, complex regional pain syndrome, hardware irritation, over- or under-correction requiring revision, and reoperation; each event graded mild, moderate or severe and summarized as incidences with Clopper-Pearson 95% confidence intervals. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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