Trial · NCT00824512
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Creatine Rephosphorylation Rate Post Exercise | Baseline (Week 0) to Week 12 | Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH. |
| Secondary | Peak Post Exercise Perfusion | Baseline (Week 0) to Week 12 | Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging. |
| Secondary | Time to Peak Perfusion | Baseline (Week 0) to Week 12 | |
| Secondary | Perfusion-time Integral During the First 9 Minutes Post Exercise. | Baseline (Week 0) to Week 12 | The integral of 'peak perfusion' over a period of 9 minutes post exercise. |
| Secondary | Muscle Reoxygenation Rate Post Exercise. | Baseline (Week 0) to Week 12 | Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy. |
| Secondary | Muscle Trophicity: Maximum Cross Section of Muscle | Baseline (Week 0) to Week 12 | Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm\^2) |
| Secondary | Developed Force During the Exercise Bout | Baseline (Week 0) to Week 12 | Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy |
| Secondary | Normalised Work Developed During the Exercise | Baseline (Week 0) to Week 12 | Normalised work developed during the exercise was derived as Work developed during the exercise/(\[60 X Maximum cross section of muscle\]-1100). Normalised work measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy. |
| Secondary | Metabolism Efficacy Index | Baseline (Week 0) to Week 12 | The metabolism efficacy index was derived as Normalised work x creatine phosphorylation rate (sec-1). \[Normalised work was derived as Work developed during the exercise/(60 X Maximum cross section of muscle-1100)\]. Greater values of Metabolism Efficacy index indicate improvement in skeletal muscle energetics while lower values indicate the reverse. Negative values obtained using the formula indicated severe levels of muscle weakness. |
| Secondary | International Cooperative Ataxia Rating Scale [ICARS] (Total Score) | Baseline (Week 0) to Week 12 | The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales (i.e. Posture and gait disturbances, Kinetic functions, Speech disorders, \& Oculomotor disorders). Scores for each subscale quantify the extent of ataxia in each clinically important area and subscale scores are also summed to give a total score ranging from 0 to 100, with 100 indicative of the most severely affected outcome. |
| Secondary | ICARS (Posture and Gait Disturbance Score) | Baseline (Week 0) to Week 12 | The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Posture and gait disturbances. Posture and gait disturbances score range from 0 to 34 (Higher scores indicate higher levels of impairment). |
| Secondary | ICARS (Kinetic Function Score) | Baseline (Week 0) to Week 12 | The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Kinetic Function. Kinetic Function score range from 0 to 52 (Higher scores indicate higher levels of impairment). |
| Secondary | ICARS (Speech Disorders Score) | Baseline (Week 0) to Week 12 | The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Speech Disorders. Speech Disorders Score range from 0 to 8 (Higher scores indicate higher levels of impairment). |
| Secondary | ICARS (Oculomotor Disorders Score) | Baseline (Week 0) to Week 12 | The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Oculomotor Disorders. Oculomotor Disorders score range from 0 to 6 (Higher scores indicate higher levels of impairment). |
| Secondary | Timed 25-foot Walk Test | Baseline (Week 0) to Week 12 | |
| Secondary | Nine Hole Peg Test (Dominant Hand) | Baseline (Week 0) to Week 12 | The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs. |
| Secondary | Nine Hole Peg Test (Nondominant Hand) | Baseline (Week 0) to Week 12 | The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs. |
| Secondary | Choice Reaction Time Test- Reaction Time | Baseline (Week 0) to Week 12 | The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key. |
| Secondary | Choice Reaction Time Test- Movement Time | Baseline (Week 0) to Week 12 | The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key. |
| Secondary | Visual Assessment Scale (VAS) of Global Impression - Patient | Baseline (Week 0) to Week 12 | The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100. |
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.
For software
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